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Study of SRF388 in Patients With Advanced Solid Tumors

Primary Purpose

Advanced Solid Tumor, Clear Cell Renal Cell Carcinoma, Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SRF388
Pembrolizumab
Sponsored by
Surface Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring metastatic solid tumors, advanced solid tumors, Phase 1, SRF388, IL-27, safety, efficacy, immunotherapy, cancer, immuno-oncology, kidney cancer, renal cell carcinoma, liver cancer, hepatocellular carcinoma, non-small cell lung cancer, pembrolizumab, PD-1

Eligibility Criteria

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

Part A and Part B Abbreviated Inclusion Criteria:

  • ≥ 18 years of age
  • Locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy, and for whom no available therapies are appropriate (based on investigator judgment)
  • Patients in Part B with advanced or metastatic ccRCC, HCC, or NSCLC must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Patients with HCC in Part B must have at least 1 measurable target lesion according to modified RECIST (mRECIST)
  • Patients with HCC must have unresectable disease, Barcelona Clinic Liver Cancer (BCLC1) Stage B (not eligible for transcatheter arterial chemoembolization [TACE]) or Stage C
  • For patients in Part B with ccRCC, demonstrated progressive disease (PD) during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with regimen(s) that have included a vascular endothelial growth factor (VEGF)-targeted agent and an immune checkpoint inhibitor. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted.
  • For patients in Part B with HCC, demonstrated PD during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with a VEGF-targeted agent. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted.
  • For Part B patients in the tumor biopsy subsets only, must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing to undergo pretreatment and on-treatment biopsies per protocol
  • Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula or serum creatinine ≤ 2.0 x the upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if elevated because of Gilbert's syndrome and ≤ 2 x ULN for patients with HCC or patients with known liver metastases)
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) < 2.5 x ULN (< 5 x ULN if liver metastasis or for patients with HCC)
  • For patients with HCC, Child-Pugh class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L)
  • Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1.0 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L. For patients with HCC, platelet count ≥ 75 x 109/L without transfusion
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients with NSCLC must have histologically confirmed locally advanced and/or metastatic Stage IV NSCLC
  • Patients with NSCLC must have demonstrated progressive disease during or after the most recent treatment regimen

Part C Abbreviated Inclusion Criteria:

  • ≥ 18 years of age
  • Advanced RCC of any histology or advanced HCC previously treated with at least one systemic anticancer therapy OR histologically or cytologically confirmed metastatic or unresectable adenocarcinoma or squamous cell NSCLC without known actionable driver mutations (e.g.,EGFR, ALK, RET, BRAFV600, ROS1, MET, NTRK).
  • Patients with HCC must have unresectable disease, Barcelona Clinic Liver Cancer (BCLC) Stage B (not eligible for transcatheter arterial chemoembolization) or Stage C
  • At least 1 measurable lesion per RECIST 1.1
  • Patients with HCC must have at least 1 measurable target lesion according to modified RECIST (mRECIST)
  • ECOG performance status of 0-1
  • ANC ≥1500/µL (1.5 x 109/L)
  • Platelets ≥100 000/µL (≥ 100 x 109/L)
  • Hemoglobin for participants with RCC: ≥9.0 g/dL; for participants with HCC: ≥8.5 g/dL
  • Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
  • Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
  • AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
  • International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
  • For patients with HCC, Child-Pugh Class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L)
  • Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study drug period (or beginning 14 days before the initiation of pembrolizumab for oral contraception), including 75 days after the last dose of SRF388 or 120 days after the last dose of pembrolizumab; male patients must refrain from donating sperm during this period. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception with spermicide. Azoospermic male patients and WCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, female patients must still undergo pregnancy testing as described in this section.

Part C Abbreviated Inclusion Criteria Specific to Patients with RCC or HCC from Part A or Part B:

  • Progressed on SRF388 by RECIST 1.1
  • Did not experience prior Grade ≥ 3 toxicity related to SRF388
  • Willingness to undergo pretreatment core or excisional biopsy if deemed safe and tumor is accessible, in the opinion of the Investigator
  • Has received no systemic anticancer therapies between SRF388 doses

Part C Abbreviated Inclusion Criteria specific to NSCLC Patients:

  • Willingness to undergo pretreatment core or excisional biopsy if deemed safe and tumor is accessible, in the opinion of the Investigator
  • Known PD-L1+ disease
  • No more than 3 prior lines of systemic therapy for unresectable or metastatic disease with prior radiologic progression on or following platinum-based chemotherapy and prior anti-PD-(L)1 therapy whether given alone or in combination

Part A and Part B Abbreviated Exclusion Criteria:

  • Previously received an anti-IL-27 antibody or anti-IL-27 targeted therapy
  • For patients in Part B with renal cell carcinoma (RCC), non-clear cell RCC histology
  • For patients with HCC, known fibrolamellar or mixed hepatocellular cholangiocarcinoma
  • History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs
  • Major surgery within 4 weeks prior to Screening
  • Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study

Part C Abbreviated Exclusion Criteria:

  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug
  • Previously received an anti-IL 27 antibody or anti-IL 27 targeted therapy (exception to patients who received SRF388 in Part A or Part B)
  • No prior systemic therapy for unresectable or metastatic disease
  • Received > 5 prior systemic regimens for unresectable or metastatic disease (prior PD-(L)1 inhibitors are allowed if the patient did not discontinue therapy due to ≥ Grade 3 drug-related toxicity)
  • For patients with HCC, fibrolamellar histology or mixed hepatocellular cholangiocarcinoma
  • For patients with HCC, moderate or severe ascites
  • For patients with HCC, inability to undergo disease evaluation with triphasic computed tomography or magnetic resonance imaging because of contrast allergy or other contraindication
  • For patients with HCC, imaging findings consistent with ≥ 50% liver occupation by HCC tumors
  • History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs
  • Surgeries that required general anesthesia must be completed at least 2 weeks before first study drug administration
  • Prior autologous stem cell transplant ≤ 3 months before the first dose
  • Prior allogeneic hematopoietic cell transplant within 6 months of the first dose or with a history of or current clinical Graft-Versus-Host Disease
  • Has had an allogenic tissue/solid organ transplant
  • Other unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study

Sites / Locations

  • City of HopeRecruiting
  • University of Southern California (USC) - Norris Comprehensive Cancer CenterRecruiting
  • UCSF Medical Center - Helen Diller Family Comprehensive Cancer CenterRecruiting
  • University of Miami Leonard M. Miller School of Medicine (UMMSM)
  • Dana Farber Cancer InstituteRecruiting
  • University of Michigan Health System (UMHS)Recruiting
  • Washington University School of Medicine - St. LouisRecruiting
  • Roswell ParkRecruiting
  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)Recruiting
  • Cleveland ClinicRecruiting
  • University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Cancer CenterRecruiting
  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI))Recruiting
  • Vanderbilt University Medical Center (VUMC)Recruiting
  • University of Texas Southwestern Medical CenterRecruiting
  • The University of Texas - MD Anderson Cancer CenterRecruiting
  • South Texas Accelerated Research TherapeuticsRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Asan Medical CenterRecruiting
  • National University HospitalRecruiting
  • National Cancer Center Singapore (NCCS)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A Monotherapy Dose Escalation

Part B Indication-specific SRF388 Monotherapy Expansion

Part C SRF388 in Combination with Pembrolizumab

Arm Description

The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of SRF388 as monotherapy in up to 42 patients with advanced solid tumors.

Part B monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of SRF388 monotherapy at the recommended phase 2 dose (RP2D) in up to 40 patients with ccRCC, up to 40 patients with HCC, and up to 40 patients with NSCLC.

Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of SRF388 in combination with pembrolizumab in patients with advanced RCC or HCC, or anti-PD(L)1 relapsed/refractory advanced NSCLC.

Outcomes

Primary Outcome Measures

[Part A] Dose Limiting Toxicity (DLT)
Evaluation of DLT of SRF388 as a monotherapy.
[Part B] Confirmed objective response rate (ORR)
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
[Part C] DLT
Evaluation of DLT of SRF388 in combination with pembrolizumab.
[Part C] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs)
Safety and tolerability of SRF388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 5.0 or higher.
[Part C -NSCLC Cohort] Objective response rate (ORR)
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.

Secondary Outcome Measures

[Part A, Part B] Safety Analysis: Summary of adverse events (AEs) and based on treatment-emergent AEs (TEAEs)
Safety and tolerability of SRF388 will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs).
[Part A, Part B, Part C] Pharmacokinetics (PK) of SRF388
Serum concentrations of SRF388 will be collected and analyzed to evaluate the PK of SRF388.
[Part A, Part B] Pharmacodynamics of SRF388 (pSTAT levels)
Pharmacodynamics of SRF388 will be evaluated in immune cell subsets via whole blood.
[Part A, Part C] Objective response rate (ORR)
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
[Part A, Part B, Part C] Duration of response (DoR)
DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occurs first.
[Part A, Part B, Part C] Disease control rate (DCR)
DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.
[Part A, Part B, Part C] Progression-free survival (PFS)
PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by applicable disease criteria or death.
[Part C] Serum concentration of EBI3
Serum will be collected to assess EBI3 correlation with outcomes.
[Part C] Anti-drug Antibodies (ADAs) to SRF388
Serum will be collected and assessed for the development of ADAs to SRF388.
[Part C - NSCLC Cohort] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs)
Safety and tolerability of SRF388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs.

Full Information

First Posted
April 30, 2020
Last Updated
August 25, 2023
Sponsor
Surface Oncology
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04374877
Brief Title
Study of SRF388 in Patients With Advanced Solid Tumors
Official Title
A Phase 1/1b Study of SRF388 in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Surface Oncology
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

Brief Summary
This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of SRF388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.
Detailed Description
This is a Phase 1/1b, open-label, first-in-human (FIH), dose-escalation and expansion study of SRF388, a monoclonal antibody targeting IL-27, as a monotherapy and in combination in patients with solid tumors that will be conducted in 3 parts: Part A: SRF388 monotherapy dose-escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of SRF388 as monotherapy in patients with advanced solid tumors. Part B: SRF388 monotherapy expansion cohorts will evaluate the safety, efficacy, tolerability, PK, and pharmacodynamics of SRF388 monotherapy in patients with advanced or metastatic ccRCC, advanced or metastatic HCC, and advanced or metastatic NSCLC in indication specific cohorts. Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of SRF388 in combination with pembrolizumab in patients with advanced RCC,HCC, or NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Clear Cell Renal Cell Carcinoma, Hepatocellular Carcinoma, Non-small Cell Lung Cancer
Keywords
metastatic solid tumors, advanced solid tumors, Phase 1, SRF388, IL-27, safety, efficacy, immunotherapy, cancer, immuno-oncology, kidney cancer, renal cell carcinoma, liver cancer, hepatocellular carcinoma, non-small cell lung cancer, pembrolizumab, PD-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A Monotherapy Dose Escalation
Arm Type
Experimental
Arm Description
The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of SRF388 as monotherapy in up to 42 patients with advanced solid tumors.
Arm Title
Part B Indication-specific SRF388 Monotherapy Expansion
Arm Type
Experimental
Arm Description
Part B monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of SRF388 monotherapy at the recommended phase 2 dose (RP2D) in up to 40 patients with ccRCC, up to 40 patients with HCC, and up to 40 patients with NSCLC.
Arm Title
Part C SRF388 in Combination with Pembrolizumab
Arm Type
Experimental
Arm Description
Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of SRF388 in combination with pembrolizumab in patients with advanced RCC or HCC, or anti-PD(L)1 relapsed/refractory advanced NSCLC.
Intervention Type
Drug
Intervention Name(s)
SRF388
Intervention Description
SRF388 is a fully human IgG1 antibody against IL-27. Inhibition of IL-27 with SRF388 reduces STAT1 phosphorylation leading to increased pro-inflammatory (anti-tumor) cytokine secretion (e.g., IFN-g, TNF-a) and decreased expression of inhibitory immune checkpoint receptors (e.g., PD-L1, TIGIT, LAG3) on immune cells that may result in anticancer therapeutic activity.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda®
Intervention Description
Pembrolizumab by intravenous (IV) infusion
Primary Outcome Measure Information:
Title
[Part A] Dose Limiting Toxicity (DLT)
Description
Evaluation of DLT of SRF388 as a monotherapy.
Time Frame
Assessed during first 28 days of treatment
Title
[Part B] Confirmed objective response rate (ORR)
Description
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
Time Frame
Up to 24 months
Title
[Part C] DLT
Description
Evaluation of DLT of SRF388 in combination with pembrolizumab.
Time Frame
Assessed during first 21 days of treatment
Title
[Part C] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs)
Description
Safety and tolerability of SRF388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs. A TEAE is an AE that emerges or worsens in the period from the first dose of study treatment to 30 days after the last dose of study drug assessed by per CTCAE version 5.0 or higher.
Time Frame
Up to 24 months
Title
[Part C -NSCLC Cohort] Objective response rate (ORR)
Description
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
[Part A, Part B] Safety Analysis: Summary of adverse events (AEs) and based on treatment-emergent AEs (TEAEs)
Description
Safety and tolerability of SRF388 will be assessed by summarizing adverse events (AEs) and will be based on treatment-emergent AEs (TEAEs).
Time Frame
Up to 24 months
Title
[Part A, Part B, Part C] Pharmacokinetics (PK) of SRF388
Description
Serum concentrations of SRF388 will be collected and analyzed to evaluate the PK of SRF388.
Time Frame
Up to 24 months
Title
[Part A, Part B] Pharmacodynamics of SRF388 (pSTAT levels)
Description
Pharmacodynamics of SRF388 will be evaluated in immune cell subsets via whole blood.
Time Frame
Up to 24 months
Title
[Part A, Part C] Objective response rate (ORR)
Description
ORR will be estimated by the percentage of patients achieving a best overall response of CR or PR per RECIST v1.1 and iRECIST.
Time Frame
Up to 24 months
Title
[Part A, Part B, Part C] Duration of response (DoR)
Description
DoR is defined as the time from the first documented response (CR or PR) to documented disease progression as determined by applicable disease criteria, or documented death due to any cause, whichever occurs first.
Time Frame
Up to 24 months
Title
[Part A, Part B, Part C] Disease control rate (DCR)
Description
DCR is defined as the percentage of patients with CR, partial PR, or stable disease lasting a minimum of 12 weeks.
Time Frame
Up to 24 months
Title
[Part A, Part B, Part C] Progression-free survival (PFS)
Description
PFS is defined as the time from the first treatment on study with study drug to documented disease progression as determined by applicable disease criteria or death.
Time Frame
Up to 24 months
Title
[Part C] Serum concentration of EBI3
Description
Serum will be collected to assess EBI3 correlation with outcomes.
Time Frame
Up to 24 months
Title
[Part C] Anti-drug Antibodies (ADAs) to SRF388
Description
Serum will be collected and assessed for the development of ADAs to SRF388.
Time Frame
Up to 24 months
Title
[Part C - NSCLC Cohort] Summary of adverse events (AEs) based on treatment emergent AEs (TEAEs)
Description
Safety and tolerability of SRF388 + pembrolizumab will be assessed by summarizing AEs and will be based on TEAEs.
Time Frame
Up tp 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Part A and Part B Abbreviated Inclusion Criteria: ≥ 18 years of age Locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy, and for whom no available therapies are appropriate (based on investigator judgment) Patients in Part B with advanced or metastatic ccRCC, HCC, or NSCLC must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Patients with HCC in Part B must have at least 1 measurable target lesion according to modified RECIST (mRECIST) Patients with HCC must have unresectable disease, Barcelona Clinic Liver Cancer (BCLC1) Stage B (not eligible for transcatheter arterial chemoembolization [TACE]) or Stage C For patients in Part B with ccRCC, demonstrated progressive disease (PD) during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with regimen(s) that have included a vascular endothelial growth factor (VEGF)-targeted agent and an immune checkpoint inhibitor. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted. For patients in Part B with HCC, demonstrated PD during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with a VEGF-targeted agent. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted. For Part B patients in the tumor biopsy subsets only, must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing to undergo pretreatment and on-treatment biopsies per protocol Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula or serum creatinine ≤ 2.0 x the upper limit of normal (ULN) Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if elevated because of Gilbert's syndrome and ≤ 2 x ULN for patients with HCC or patients with known liver metastases) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) < 2.5 x ULN (< 5 x ULN if liver metastasis or for patients with HCC) For patients with HCC, Child-Pugh class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L) Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1.0 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L. For patients with HCC, platelet count ≥ 75 x 109/L without transfusion Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients with NSCLC must have histologically confirmed locally advanced and/or metastatic Stage IV NSCLC Patients with NSCLC must have demonstrated progressive disease during or after the most recent treatment regimen Part C Abbreviated Inclusion Criteria: ≥ 18 years of age Advanced RCC of any histology or advanced HCC previously treated with at least one systemic anticancer therapy OR histologically or cytologically confirmed metastatic or unresectable adenocarcinoma or squamous cell NSCLC Patients with HCC must have unresectable disease, Barcelona Clinic Liver Cancer (BCLC) Stage B (not eligible for transcatheter arterial chemoembolization) or Stage C At least 1 measurable lesion per RECIST 1.1 Patients with HCC must have at least 1 measurable target lesion according to modified RECIST (mRECIST) ECOG performance status of 0-1 ANC ≥1500/µL (1.5 x 109/L) Platelets ≥100 000/µL (≥ 100 x 109/L) Hemoglobin for participants with RCC: ≥9.0 g/dL; for participants with HCC: ≥8.5 g/dL Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants For patients with HCC, Child-Pugh Class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L) Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study drug period (or beginning 14 days before the initiation of pembrolizumab for oral contraception), including 75 days after the last dose of SRF388 or 120 days after the last dose of pembrolizumab; male patients must refrain from donating sperm during this period. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception with spermicide. Azoospermic male patients and WCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, female patients must still undergo pregnancy testing as described in this section. Part C Abbreviated Inclusion Criteria Specific to Patients with RCC or HCC from Part A or Part B: Progressed on SRF388 by RECIST 1.1 Did not experience prior Grade ≥ 3 toxicity related to SRF388 Willingness to undergo pretreatment core or excisional biopsy if deemed safe and tumor is accessible, in the opinion of the Investigator Has received no systemic anticancer therapies between SRF388 doses Part C Abbreviated Inclusion Criteria specific to NSCLC Patients: No more than 3 prior lines of systemic therapy for unresectable or metastatic disease with prior radiologic progression on or following platinum-based chemotherapy and prior anti-PD-(L)1 therapy whether given alone or in combination Part A and Part B Abbreviated Exclusion Criteria: Previously received an anti-IL-27 antibody or anti-IL-27 targeted therapy For patients in Part B with renal cell carcinoma (RCC), non-clear cell RCC histology For patients with HCC, known fibrolamellar or mixed hepatocellular cholangiocarcinoma History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs Major surgery within 4 weeks prior to Screening Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study Part C Abbreviated Exclusion Criteria: Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug Previously received an anti-IL 27 antibody or anti-IL 27 targeted therapy (exception to patients who received SRF388 in Part A or Part B) No prior systemic therapy for unresectable or metastatic disease Received > 4 prior systemic regimens for unresectable or metastatic disease (prior PD-(L)1 inhibitors are allowed if the patient did not discontinue therapy due to ≥ Grade 3 drug-related toxicity) For patients with HCC, fibrolamellar histology or mixed hepatocellular cholangiocarcinoma For patients with HCC, moderate or severe ascites For patients with HCC, inability to undergo disease evaluation with triphasic computed tomography or magnetic resonance imaging because of contrast allergy or other contraindication For patients with HCC, imaging findings consistent with ≥ 50% liver occupation by HCC tumors History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs Surgeries that required general anesthesia must be completed at least 2 weeks before first study drug administration Prior autologous stem cell transplant ≤ 3 months before the first dose Prior allogeneic hematopoietic cell transplant within 6 months of the first dose or with a history of or current clinical Graft-Versus-Host Disease Has had an allogenic tissue/solid organ transplant Other unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Bowers
Phone
1-978-954-7207
Email
bbowers@surfaceoncology.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Harshman, MD
Organizational Affiliation
Surface Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daneng Li
Phone
626-471-9200
First Name & Middle Initial & Last Name & Degree
Daneng Li, MD
Facility Name
University of Southern California (USC) - Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiomara Menendez, RN
Phone
323-409-4368
Email
menendez_x@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Lisa Harton, MS
Phone
(323) 865-0454
Email
Lisa.Harton@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Anthony El-Khoueiry, MD
Facility Name
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ria Conti
Phone
415-514-2259
Email
Maria.Conti@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Arpita Desai, MD
Facility Name
University of Miami Leonard M. Miller School of Medicine (UMMSM)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Completed
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karly Griffin
Phone
617-632-6287
Email
Karly_Griffin@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Charlene Mantia, MD
Facility Name
University of Michigan Health System (UMHS)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breanna Bladowski
Phone
734-936-7813
Email
bbladows@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Ulka Vaishampayan, MD
Facility Name
Washington University School of Medicine - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allie Gordon
Phone
314-747-5543
Email
Allison.gordon@wustl.edu
First Name & Middle Initial & Last Name & Degree
Katlyn Kraft
Phone
314-747-5440
Email
katlyn.kraft@wustl.edu
First Name & Middle Initial & Last Name & Degree
Daniel Morgensztern, MD
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rushka Kallicharan Smith
Email
Rushka.Kallicharan-Smith@RoswellPark.org
First Name & Middle Initial & Last Name & Degree
Saby George, MD
Facility Name
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Lucas
Phone
929-489-5016
Email
natalie.lucas@mssm.edu
First Name & Middle Initial & Last Name & Degree
Kathy Wu
Phone
646-965-0898
Email
kathy.wu@mssm.edu
First Name & Middle Initial & Last Name & Degree
Thomas Marron, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
taussigresearch@ccf.org
First Name & Middle Initial & Last Name & Degree
Moshe Ornstein, MD
Facility Name
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
405-271-8778
Email
Phase1-Referrals@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Abdul Naqash, MD
Facility Name
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI))
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Brenneman
Phone
412-623-2293
Email
brennemana2@upmc.edu
First Name & Middle Initial & Last Name & Degree
Leonard Appleman, MD
Facility Name
Vanderbilt University Medical Center (VUMC)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VICC Recruitment and Eligibility Office
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Brian Rini, MD
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Rowell
Phone
214-648-7001
Email
Amy.Rowell@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Hans Hammers, MD
Facility Name
The University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serdar A. Gurses, PhD
Phone
713-563-9710
Email
sagurses@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Yanyan Tian, PhD
Phone
713-792-7274
Email
ytian@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Aung Naing, MD
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Galindo
Phone
210-593-5202
Email
angela.galindo@startsa.com
First Name & Middle Initial & Last Name & Degree
Amita Patnaik, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyunJoo Ryu
Phone
+82-2-6072-5175
Email
rhjstar@hanmail.net
First Name & Middle Initial & Last Name & Degree
Tae-Yong Kim, MD
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiwon Kim
Phone
82-2-2228-8048
Email
kimjw627@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeoJin Moon
Phone
82-2-3010-8351
Email
jinn@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Ean Chee, MD
Phone
(65) 6779 5555
Email
cheng_ean_chee@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Shi Jian Eric Foo
Phone
(65)92478406
Email
Shi_Jian_FOO@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Cheng Ean Cheng Ean, MD
Facility Name
National Cancer Center Singapore (NCCS)
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of SRF388 in Patients With Advanced Solid Tumors

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