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Monoclonal Antibodies

SRF388 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Coherus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with NSCLC must have histologically confirmed locally advanced and/or metastatic Stage IV NSCLC
For patients with HCC, Child-Pugh Class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug that targets a protein involved in inflammation. The drug will be given to patients with cancer to see if it is safe and effective.

Who is the study for?
Adults with advanced solid tumors, including specific types of lung, liver, and kidney cancer. Participants must have progressed after standard therapy and meet certain health criteria like stable organ function and blood counts. They should not have had major surgery recently or severe allergies to monoclonal antibodies.Check my eligibility
What is being tested?
The trial is testing SRF388 alone or with Pembrolizumab in patients with various advanced cancers. It's a first-in-human study to see how well these treatments work and what the best doses might be.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, changes in liver enzymes or blood counts that could indicate liver or bone marrow issues, and potential immune system-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at an advanced stage and has been confirmed by tests.
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My liver cancer is moderately severe, but my liver is still functioning well.
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My liver cancer has a measurable tumor according to specific criteria.
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My advanced cancer has worsened despite treatment, and no other treatments are suitable for me.
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I agree to use birth control during and after the study as required.
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I have a measurable tumor in my kidney, liver, or lung cancer.
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My kidney cancer worsened after treatment with specific drugs.
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I have advanced kidney or liver cancer treated before, or my lung cancer can't be removed by surgery.
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My cancer has worsened despite treatment with SRF388.
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My NSCLC has worsened despite recent treatment.
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I haven't taken any cancer drugs between my SRF388 doses.
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My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.
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My liver cancer worsened during or after my last treatment, which included a VEGF-targeted therapy.
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My blood counts meet the required levels for treatment.
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My liver cancer is moderately advanced, but my liver is still functioning well.
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I've had 3 or fewer treatments for my cancer that can't be removed by surgery, including chemotherapy and immunotherapy.
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I am fully active or can carry out light work.
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I have not had severe side effects from SRF388 treatment.
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My kidney function, measured by creatinine or GFR, is within the required range.
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My liver cancer cannot be surgically removed and is at an advanced stage.
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I am 18 years old or older.
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My tumor can be biopsied before and during treatment, and I agree to these procedures.
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I am fully active or can carry out light work.
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My kidney function, measured by creatinine clearance, is within the required range.
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I have liver cancer with at least one measurable tumor.
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My liver function tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
[Part A] Dose Limiting Toxicity (DLT)
[Part B] Confirmed objective response rate (ORR)
[Part C -NSCLC Cohort] Objective response rate (ORR)
+3 more
Secondary outcome measures
[Part A, Part B, Part C, Part D] Disease control rate (DCR)
[Part A, Part B, Part C, Part D] Duration of response (DoR)
[Part A, Part B, Part C, Part D] Progression-free survival (PFS)
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part D CHS-388 in Combination with ToripalimabExperimental Treatment2 Interventions
Part D will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab in patients with anti-PD(L)1 relapsed/refractory advanced NSCLC.
Group II: Part C CHS-388 in Combination with PembrolizumabExperimental Treatment2 Interventions
Part C will evaluate the safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab in patients with advanced RCC or HCC, or anti-PD(L)1 relapsed/refractory advanced NSCLC.
Group III: Part B CHS-388 Monotherapy ExpansionExperimental Treatment1 Intervention
Part B monotherapy expansion will evaluate the safety, tolerability, PK, pharmacodynamics, and efficacy of CHS-388 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.
Group IV: Part A Monotherapy Dose EscalationExperimental Treatment1 Intervention
The Part A monotherapy dose escalation portion of the study will evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of CHS-388 as monotherapy in up to 30 patients with advanced solid tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Toripalimab
2017
Completed Phase 2
~680
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Coherus Biosciences, Inc.Lead Sponsor
11 Previous Clinical Trials
3,016 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,775 Total Patients Enrolled
Surface OncologyLead Sponsor
5 Previous Clinical Trials
429 Total Patients Enrolled

Media Library

SRF388 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04374877 — Phase 1
Renal Cell Carcinoma Research Study Groups: Part B CHS-388 Monotherapy Expansion, Part C CHS-388 in Combination with Pembrolizumab, Part D CHS-388 in Combination with Toripalimab, Part A Monotherapy Dose Escalation
Renal Cell Carcinoma Clinical Trial 2023: SRF388 Highlights & Side Effects. Trial Name: NCT04374877 — Phase 1
SRF388 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374877 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored for this clinical research?

"To properly carry out this medical trial, 220 participants with the correct inclusion criteria must be enrolled. Those who wish to participate can do so at Vanderbilt University Medical Center in Nashville and the University of Texas Southwestern Medical Centre in Dallas."

Answered by AI

What indications has SRF388 been employed to address?

"SRF388 is generally prescribed to treat cancerous tumors. Additionally, it can be used for conditions such as unresectable melanoma, microsatellite instability high, and chemotherapy resistance."

Answered by AI

What potential hazards may be associated with SRF388 for individuals?

"The safety of SRF388 is estimated to be a 1 as this Phase 1 study has only minimal data backing its efficacy and security."

Answered by AI

Has the efficacy of SRF388 been evaluated in any other scientific trials?

"Presently, 961 trials are underway for SRF388. Of those studies, 122 have reached Phase 3 testing. Houston is the epicentre of research into this treatment with 35731 sites performing clinical tests related to it."

Answered by AI

Are there any vacancies available to participate in the experiment?

"Yes, the information on clinicaltrials.gov verifies that this trial is still recruiting participants and has been since April of 2020. Last edited in August 2022, it seeks to enroll 220 individuals at 17 different sites."

Answered by AI

What are the intended outcomes of this experiment?

"This clinical trial's primary endpoint is to assess the safety and tolerability of SRF388 + pembrolizumab by summarizing treatment-emergent adverse events (TEAEs) during the first 28 days of treatment. Secondary endpoints include establishing a similar Safety Analysis for SRF388 alone, as well as examining Pharmacokinetics of both medications over time."

Answered by AI

At how many sites is the trial being conducted?

"The research team at VUMC, UT Southwestern Medical Centre, City of Hope and 17 other medical centres are all conducting this clinical trial."

Answered by AI
~78 spots leftby Dec 2025