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Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Primary Purpose

Neoplasm Metastasis

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-07265807
Sasanlimab
Axitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring TAMK (TAM kinase), MER (mer proto-oncogene), MERTK (mer proto-oncogene tyrosine kinase), AXL (AXL receptor tyrosine kinase), AXL/MER, Selective kinase inhibitor, PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1), Immune modulator, Advanced Cancer, Metastatic Cancer, Solid Tumor Cancer, Metastatic Solid Tumor, Cervical Cancer, Gastric Cancer, Esophageal Cancer, Endometrial Cancer, Hepatocellular carcinoma (HCC), Melanoma, Merkel Cell Carcinoma, High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Renal cell carcinoma (RCC), Urothelial carcinoma, Colorectal cancer (CRC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1
  • ECOG Performance Status 0 or 1, 2 with approval
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Resolved acute effects of any prior therapy
  • Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
  • Life expectancy of at least 3 months.
  • Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
  • Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
  • Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
  • Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.

Exclusion Criteria:

  • Known active uncontrolled or symptomatic CNS metastases.
  • Any other active malignancy within 2 years prior to enrollment.
  • Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry.
  • Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy.
  • Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol.
  • Retinal or other serious ophthalmic disorders as defined in protocol.
  • Clinically significant cardiac disease as defined in protocol.
  • Uncontrolled HTN that cannot be controlled by medications.
  • Inability to consume or absorb study drug.
  • Known or suspected hypersensitivity to PF-07265807.
  • Prohibited concomitant medications as defined in protocol.
  • Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
  • Active bleeding disorder.
  • Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
  • Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.

For Part 2, Part 3, and Part 4, Cohorts 2-4:

- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.

Sites / Locations

  • Henry Eye Clinic
  • Highlands Oncology Group
  • Highlands Oncology Group
  • Highlands Oncology Group
  • UC Irvine Health
  • UC Irvine Medical Center
  • UC Irvine Health
  • UCI Chao Family Comprehensive Cancer Center
  • UCI Medical Center- Outpatient Pharmacy
  • UCI/Chao Family Comprehensive Cancer Center
  • Clinical & Translational Science Institute
  • UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • UCSF Investigational Drugs Pharmacy
  • Rocky Mountain Lions Eye Institute (RMLEI)
  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
  • Community Health Network, Inc.
  • Community Health Network, Inc.
  • Community Health Network Cancer Center North
  • Community Health Network Investigational Drug Services
  • Community Health Network, Inc.
  • Community Health Network, Inc.
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • Dana Farber Cancer Institute
  • Dana-Farber Cancer Institute - Chestnut Hill
  • Hackensack University Medical Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Duke Eye Center
  • Duke University Medical Center
  • The University of Texas M. D. Anderson Cancer Center
  • HPS Pharmacies Darlinghurst
  • Macquarie University
  • St Vincent's Hospital
  • Calvary Mater Newcastle
  • Cross Cancer Institute
  • Hamilton Health Sciences-Juravinski Cancer Centre
  • University Health Network
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
  • CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
  • Guangdong Provincial People's Hospital
  • Jilin Province Tumor Hospital
  • Azienda Ospedaliero Universitaria delle Marche
  • Fondazione IRCCS San Gerardo dei Tintori
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Istituto Europeo di Oncologia IRCCS
  • Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
  • Chayagasaka Eye Clinic
  • National Cancer Center Hospital East
  • Aichi Cancer Center Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Severance Hospital, Yonsei University Health System
  • Severance Hospital
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Fundacion Jimenez Díaz
  • Hospital Universitario HM Sanchinarro
  • Hospital Clinico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Monotherapy Dose Escalation: Part 1

Doublet Dose Escalation: Part 2

Triplet Dose Escalation: Part 3

Expansion Phase: Part 4, Cohort 1

Expansion Phase: Part 4, Cohort 2

Expansion Phase: Part 4, Cohort 3

Expansion Phase: Part 4, Cohort 4

Arm Description

Monotherapy dose escalation of PF-07265807 in participants with select tumor types.

Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.

Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.

PF-07265807 monotherapy in participants with METex14 mutant NSCLC.

PF-07265807 with sasanlimab in participants with MSS CRC

PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ

PF-07265807 with sasanlimab plus axitinib in participants with RCC

Outcomes

Primary Outcome Measures

Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Part 4: Overall Response Rate (ORR)
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Part 4, Cohort 4: Complete Response (CR)
Response will be evaluated via radiographical tumor assessment by RECIST v1.1

Secondary Outcome Measures

Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Single dose (Tmax) pharmacokinetic parameters of sasanlimab
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Single dose (AUClast) pharmacokinetic parameters of sasanlimab
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab
Parts 1, 2, and 3: ORR
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Part 4: Number of participants with treatment emergent AEs
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Part 4: Number of participants with laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Incidence and titer of anti-sasanlimab ADA response
Duration of Response
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Disease Control Rate
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Progression Free Survival
Response will be evaluable via radiographical tumor assessment by RECIST v1.1

Full Information

First Posted
June 24, 2020
Last Updated
September 8, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04458259
Brief Title
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Official Title
A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
TAMK (TAM kinase), MER (mer proto-oncogene), MERTK (mer proto-oncogene tyrosine kinase), AXL (AXL receptor tyrosine kinase), AXL/MER, Selective kinase inhibitor, PD-1 (programmed cell death protein 1), PD-L1 (programmed cell death ligand 1), Immune modulator, Advanced Cancer, Metastatic Cancer, Solid Tumor Cancer, Metastatic Solid Tumor, Cervical Cancer, Gastric Cancer, Esophageal Cancer, Endometrial Cancer, Hepatocellular carcinoma (HCC), Melanoma, Merkel Cell Carcinoma, High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Renal cell carcinoma (RCC), Urothelial carcinoma, Colorectal cancer (CRC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation and expansion
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy Dose Escalation: Part 1
Arm Type
Experimental
Arm Description
Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
Arm Title
Doublet Dose Escalation: Part 2
Arm Type
Experimental
Arm Description
Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
Arm Title
Triplet Dose Escalation: Part 3
Arm Type
Experimental
Arm Description
Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
Arm Title
Expansion Phase: Part 4, Cohort 1
Arm Type
Experimental
Arm Description
PF-07265807 monotherapy in participants with METex14 mutant NSCLC.
Arm Title
Expansion Phase: Part 4, Cohort 2
Arm Type
Experimental
Arm Description
PF-07265807 with sasanlimab in participants with MSS CRC
Arm Title
Expansion Phase: Part 4, Cohort 3
Arm Type
Experimental
Arm Description
PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
Arm Title
Expansion Phase: Part 4, Cohort 4
Arm Type
Experimental
Arm Description
PF-07265807 with sasanlimab plus axitinib in participants with RCC
Intervention Type
Drug
Intervention Name(s)
PF-07265807
Other Intervention Name(s)
ARRY-067
Intervention Description
Given 2 weeks on/1 week off
Intervention Type
Drug
Intervention Name(s)
Sasanlimab
Other Intervention Name(s)
PF-06801591; RN-888
Intervention Description
Given SC Q3W
Intervention Type
Drug
Intervention Name(s)
Axitinib
Other Intervention Name(s)
AG-013736; Inlyta
Intervention Description
Dosed per package label starting with 5 mg PO BID
Primary Outcome Measure Information:
Title
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
Description
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Time Frame
Baseline through day 21 or 42
Title
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
Description
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Time Frame
Baseline through approximately 2 years
Title
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Time Frame
Baseline through approximately 2 years
Title
Part 4: Overall Response Rate (ORR)
Description
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years
Title
Part 4, Cohort 4: Complete Response (CR)
Description
Response will be evaluated via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years
Secondary Outcome Measure Information:
Title
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Description
Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Description
Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Description
Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib
Time Frame
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Title
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Description
Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Description
Single dose (Tmax) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Description
Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib
Time Frame
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Title
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Description
Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Description
Single dose (AUClast) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Description
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Description
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib
Time Frame
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Title
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
Description
As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
Description
As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
Description
As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
Description
As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
Description
As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
Description
As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
Description
As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Title
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
Description
As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab
Time Frame
Through study completion, an average of 1 year
Title
Parts 1, 2, and 3: ORR
Description
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years
Title
Part 4: Number of participants with treatment emergent AEs
Description
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Time Frame
Baseline through approximately 2 years
Title
Part 4: Number of participants with laboratory abnormalities
Description
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Time Frame
Baseline through approximately 2 years
Title
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Description
Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Title
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Description
Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Time Frame
Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Title
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Description
Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab
Time Frame
Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Title
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Description
Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib
Time Frame
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Title
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Description
Incidence and titer of anti-sasanlimab ADA response
Time Frame
Through study completion, an average of 1 year
Title
Duration of Response
Description
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years
Title
Disease Control Rate
Description
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years
Title
Progression Free Survival
Description
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Time Frame
Baseline through approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not previously irradiated, as defined by RECIST 1.1 ECOG Performance Status 0 or 1, 2 with approval Adequate Bone Marrow Function Adequate Renal Function Adequate Liver Function Resolved acute effects of any prior therapy Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort). Life expectancy of at least 3 months. Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors. Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available. Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy. Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy. Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy. Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease. Exclusion Criteria: Known active uncontrolled or symptomatic CNS metastases. Any other active malignancy within 2 years prior to enrollment. Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry. Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy. Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol. Retinal or other serious ophthalmic disorders as defined in protocol. Clinically significant cardiac disease as defined in protocol. Uncontrolled HTN that cannot be controlled by medications. Inability to consume or absorb study drug. Known or suspected hypersensitivity to PF-07265807. Prohibited concomitant medications as defined in protocol. Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption. Active bleeding disorder. Discontinuation of prior checkpoint inhibitor for treatment-related toxicity. Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent. Prior treatment with selective AXL/MERTK inhibitors For participants receiving sasanlimab: - Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Henry Eye Clinic
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Highlands Oncology Group
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCI Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCI Medical Center- Outpatient Pharmacy
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCI/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical & Translational Science Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
UCSF Investigational Drugs Pharmacy
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Rocky Mountain Lions Eye Institute (RMLEI)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Community Health Network Cancer Center North
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Community Health Network Investigational Drug Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Community Health Network, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute - Chestnut Hill
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
HPS Pharmacies Darlinghurst
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Macquarie University
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
St Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
CHU de Quebec-Universite Laval - Hotel Dieu de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Jilin Province Tumor Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Azienda Ospedaliero Universitaria delle Marche
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
City
Roma
State/Province
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Chayagasaka Eye Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-0092
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Nagoya, Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Songpa-gu
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4201002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

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