SRF388 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SRF388, a monoclonal antibody designed to help people with advanced solid tumors, including certain types of lung, liver, and kidney cancer. The trial will assess the safety and effectiveness of SRF388 both alone and in combination with other cancer-fighting drugs, such as Pembrolizumab (also known as KEYTRUDA). Potential participants should have these types of cancers that have not responded to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that SRF388, when used alone, is generally safe. In studies with advanced solid tumors, patients usually tolerated it well. No serious side effects were directly linked to SRF388, although some experienced mild issues like tiredness and nausea.
When combined with pembrolizumab, SRF388 also appeared safe. Patients with liver cancer showed positive responses and manageable side effects. The combination was generally well-tolerated, with similar mild side effects as when SRF388 was used alone.
These findings suggest that both treatments are safe. However, since the study remains in its early stages, the primary goal is to further confirm these safety results.12345Why are researchers excited about this trial's treatments?
Researchers are excited about SRF388 because it offers a fresh approach to treating cancers like renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and non-small cell lung cancer (NSCLC). Unlike standard treatments that often target surface proteins or specific cancer pathways, SRF388 works by inhibiting IL-27, a cytokine that can suppress the immune system's ability to fight cancer. The combination of SRF388 with pembrolizumab or toripalimab, which are immune checkpoint inhibitors, could enhance the immune response against tumors that have become resistant to traditional therapies. This novel mechanism of action and potential for synergy with existing immunotherapies has researchers hopeful for improved outcomes in patients with advanced cancers.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that SRF388, a monoclonal antibody, can help treat solid tumors by blocking a protein called IL-27. In earlier studies, SRF388 proved effective for patients with non-small cell lung cancer (NSCLC) and other solid tumors. This trial includes a treatment arm where participants receive SRF388 combined with pembrolizumab, a well-known cancer treatment. This combination may further enhance the body's immune response. Early results suggest that this combination could be effective for patients with certain advanced cancers.12356
Who Is on the Research Team?
Koho Iizuka, MD
Principal Investigator
Coherus BioSciences
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
CHS-388 monotherapy dose-escalation portion to evaluate safety, tolerability, PK, pharmacodynamics, and preliminary efficacy
Monotherapy Expansion
CHS-388 monotherapy expansion to evaluate safety, efficacy, tolerability, PK, and pharmacodynamics in specific cohorts
Combination Therapy with Pembrolizumab
Evaluation of safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with pembrolizumab
Combination Therapy with Toripalimab
Evaluation of safety, preliminary efficacy, tolerability, and PK of CHS-388 in combination with toripalimab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- SRF388
Find a Clinic Near You
Who Is Running the Clinical Trial?
Coherus Biosciences, Inc.
Lead Sponsor
Coherus Oncology, Inc.
Lead Sponsor
Surface Oncology
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharpe & Dohme Corp.
Collaborator