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Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

Primary Purpose

Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-07263689

Sasanlimab

About this trial

This is an interventional treatment trial for Renal Cell Cancer focused on measuring Advanced malignancies

Eligibility Criteria

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

Inclusion Criteria:

Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents
Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 [PDL1] if applicable) or for whom no standard therapy is available for their tumor type
Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020)
Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only)
Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy
Eastern Cooperative Oncology Group (ECOG) PS 0-1
Adequate hematologic, renal, and liver functions
Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria.
Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2)

Exclusion Criteria:

Other active malignancy
Recent major surgery
Systemic anticancer therapy and chemotherapy within protocol-defined washout period
Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years
Current or history of myocarditis or congestive heart failure (New York Heart Association [NYHA] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction
Active or history of interstitial lung disease (ILD)/pneumonitis
Patients requiring chronic systemic immunosuppressants
History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy
Known symptomatic brain metastases requiring steroids
History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment
Any prior or planned organ transplant
Presence of any open, active wound requiring treatment

Sites / Locations

City of Hope
Columbia University Medical Center
CUMC Research Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Monotherapy dose escalation (Part 1A)

Combination dose escalation (Part 1B)

Dose expansion (Part 2) - Tumor specific Arm A

Dose expansion (Part 2) - Tumor specific Arm B

Dose expansion (Part 2) - Tumor specific Arm C

Arm Description

Participants will receive PF-07263689 once a week for 4 doses

Participants will receive PF-07263689 intravenous (IV) once week for 4 doses in combination with sasanlimab subcutaneous (SC) once every 4 weeks

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicities (DLTs) in Dose escalation (Part 1A and 1B)

DLTs will be evaluated in Part 1A and Part 1B. The number of DLTs will be used to determine the dose escalation decision and recommended dose for PF-07263689

Number of participants with adverse events

Number of participants with clinically significant laboratory abnormalities

Objective response rate in the dose expansion (Part 2) arms

Tumor response as assessed using RECIST 1.1

Secondary Outcome Measures

Objective response rate in dose escalation (Part 1A and 1B)

Tumor response as assessed using RECIST 1.1

Maximum concentration (Cmax) of viral load titer of PF-07263689

Time to maximal plasma concentration (Tmax) of viral load titer after PF-07263689 dosing

Area under the Curve from time 0 to the last measurable timepoint (AUClast) of viral load titer after PF-07263689 dosing

Viral titers for vector shedding of PF-07263689 in saliva, urine, injection site swab, and swab from any spontaneous skin pox lesion

Sasanlimab trough concentration (Part 1B and 2)

Incidence and titers of anti-IL2 antibodies and anti-drug antibody (ADA) against PF-07263689 and sasanlimab as applicable

Anti-tumor activity (Part 2)

Disease control rate, duration of response, progression free survival, and time to progression as assessed by RECIST 1.1

Overall survival (Part 2)

Proportion of participants alive

Full Information

NCT ID

NCT05061537

First Posted

September 22, 2021

Last Updated

March 29, 2023

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT05061537

Brief Title

Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

Official Title

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY AND PHARMACODYNAMICS OF PF-07263689, EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PREVIOUSLY TREATED PARTICIPANTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated by the Sponsor due to business decision and not due to any safety concerns with PF-07263689. There are no changes to the risk-benefit for participants who have received PF-07263689 in the study.

Study Start Date

October 20, 2021 (Actual)

Primary Completion Date

October 14, 2022 (Actual)

Study Completion Date

October 14, 2022 (Actual)

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

5. Study Description

Brief Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 [PD-1] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them. The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Cancer, Melanoma, Non-Small-Cell Lung Cancer, Hepatocellular Cancer, Bladder Cancer, Sarcoma, Head and Neck Cancer, Colorectal Cancer, Ovarian Cancer, Squamous Cell Carcinoma

Keywords

Advanced malignancies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monotherapy dose escalation (Part 1A)

Arm Type

Experimental

Arm Description

Participants will receive PF-07263689 once a week for 4 doses

Arm Title

Combination dose escalation (Part 1B)

Arm Type

Experimental

Arm Description

Participants will receive PF-07263689 intravenous (IV) once week for 4 doses in combination with sasanlimab subcutaneous (SC) once every 4 weeks

Arm Title

Dose expansion (Part 2) - Tumor specific Arm A

Arm Type

Experimental

Arm Description

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Arm Title

Dose expansion (Part 2) - Tumor specific Arm B

Arm Type

Experimental

Arm Description

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Arm Title

Dose expansion (Part 2) - Tumor specific Arm C

Arm Type

Experimental

Arm Description

Participants will receive PF-07263689 IV once week for 4 doses in combination with sasanlimab SC once every 4 weeks

Intervention Type

Biological

Intervention Name(s)

PF-07263689

Intervention Description

Genetically engineered oncolytic vaccinia virus

Intervention Type

Biological

Intervention Name(s)

Sasanlimab

Intervention Description

A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Primary Outcome Measure Information:

Title

Number of participants with dose limiting toxicities (DLTs) in Dose escalation (Part 1A and 1B)

Description

DLTs will be evaluated in Part 1A and Part 1B. The number of DLTs will be used to determine the dose escalation decision and recommended dose for PF-07263689

Time Frame

Baseline through 28 days after first dose

Title

Number of participants with adverse events

Time Frame

Baseline through up to 2 years

Title

Number of participants with clinically significant laboratory abnormalities

Time Frame

Baseline through 90 days after first dose

Title

Objective response rate in the dose expansion (Part 2) arms

Description

Tumor response as assessed using RECIST 1.1

Time Frame

Baseline through up to 2 years or until disease progression

Secondary Outcome Measure Information:

Title

Objective response rate in dose escalation (Part 1A and 1B)

Description

Tumor response as assessed using RECIST 1.1

Time Frame

Baseline through 2 years or disease progression

Title

Maximum concentration (Cmax) of viral load titer of PF-07263689

Time Frame

Day 1 and Day 8 (days of dosing): Pre-dose, 0.5, 1, 4, 8, 25, 48, 72 hours post-dose; Day 15 and Day 22 (days of dosing): Pre-dose and 4 hours post-dose; and at 28 days after first dose

Title

Time to maximal plasma concentration (Tmax) of viral load titer after PF-07263689 dosing

Time Frame

Day 1 and Day 8 (days of dosing): Pre-dose, 0.5, 1, 4, 8, 25, 48, 72 hours post-dose; Day 15 and Day 22 (days of dosing): Pre-dose and 4 hours post-dose; and at 28 days after first dose

Title

Area under the Curve from time 0 to the last measurable timepoint (AUClast) of viral load titer after PF-07263689 dosing

Time Frame

Day 1 and Day 8 (days of dosing): Pre-dose, 0.5, 1, 4, 8, 25, 48, 72 hours post-dose; Day 15 and Day 22 (days of dosing): Pre-dose and 4 hours post-dose; and at 28 days after first dose

Title

Viral titers for vector shedding of PF-07263689 in saliva, urine, injection site swab, and swab from any spontaneous skin pox lesion

Time Frame

Baseline and during 30, 45, and 60 days after the last dose

Title

Sasanlimab trough concentration (Part 1B and 2)

Time Frame

Day 1 (pre-dose), 8, 15, and 22 of Cycle 1; and on Day 1 (pre-dose) of each subsequent cycle

Title

Incidence and titers of anti-IL2 antibodies and anti-drug antibody (ADA) against PF-07263689 and sasanlimab as applicable

Time Frame

Baseline through End of Treatment and up to about 2 years

Title

Anti-tumor activity (Part 2)

Description

Disease control rate, duration of response, progression free survival, and time to progression as assessed by RECIST 1.1

Time Frame

Baseline through up to 2 years or until disease progression

Title

Overall survival (Part 2)

Description

Proportion of participants alive

Time Frame

Baseline through up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of locally advanced or metastatic solid tumors known to have approved therapies using immune checkpoint inhibitors or anti-vascular endothelial growth factor agents Have exhausted (or refuse) all available standard of care therapy (e.g., including anti-PD1/programmed death ligand 1 [PDL1] if applicable) or for whom no standard therapy is available for their tumor type Patients with prior anti-PD1/PDL1 must have documentation of primary or secondary resistance to last prior anti-PD1/PDL1 therapy according to Immunotherapy Resistance Committee (SITC) (Kluger et al, 2020) Have at least 1 measurable lesion by RECIST 1.1 that has not been previously irradiated (for Part 2 only) Have recently obtained archival tumor tissue sample available, or undergo de novo tumor biopsy Eastern Cooperative Oncology Group (ECOG) PS 0-1 Adequate hematologic, renal, and liver functions Dose Escalation (Part 1A and 1B): Any advanced or metastatic solid tumor fulfilling other relevant eligibility criteria. Dose Expansion (Part 2): Tumor specific cohorts (NSCLC, RCC, melanoma, MSS CRC) must have received prior approved therapies (Part 2) Exclusion Criteria: Other active malignancy Recent major surgery Systemic anticancer therapy and chemotherapy within protocol-defined washout period Known or suspected hypersensitivity to prior treatment with any vaccinia oncolytic, pox virus, or antiviral agents within the past 10 years Current or history of myocarditis or congestive heart failure (New York Heart Association [NYHA] III-IV); unstable angina; or serious uncontrolled arrhythmia or recent myocardial infarction Active or history of interstitial lung disease (ILD)/pneumonitis Patients requiring chronic systemic immunosuppressants History of severe immune mediated side effect that was considered related to prior immune modulatory therapy and requiring immunosuppressive therapy Known symptomatic brain metastases requiring steroids History of or ongoing severe inflammatory skin conditions or severe eczema having required medical treatment Any prior or planned organ transplant Presence of any open, active wound requiring treatment

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

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

CUMC Research Pharmacy

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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=C4651001

Description

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Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

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