CLN-617 + Pembrolizumab for Solid Tumors
Trial Summary
What is the purpose of this trial?
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like systemic anticancer treatments, immunotherapy, and immunosuppressive medications must not be taken within a specific period before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment CLN-617 + Pembrolizumab for solid tumors?
What safety information is available for the treatment CLN-617 + Pembrolizumab?
Pembrolizumab, also known as Keytruda, has been studied for safety in various conditions. It can cause side effects like fatigue, cough, nausea, and more serious immune-related issues such as pneumonitis (lung inflammation), colitis (colon inflammation), and thyroid problems. In nonhuman primate studies, pembrolizumab showed no significant toxic effects.678910
What makes the drug CLN-617 + Pembrolizumab unique for treating solid tumors?
The combination of CLN-617, an IL2/IL12 fusion protein, with Pembrolizumab (Keytruda) is unique because it combines a novel fusion protein that may enhance immune response with an established immune checkpoint inhibitor that blocks PD-1, potentially offering a more effective approach to activating the immune system against solid tumors.6791011
Eligibility Criteria
Adults (18+) with advanced solid tumors who have measurable lesions, appropriate for pembrolizumab treatment, and a life expectancy of at least 12 weeks. They must have normal organ function, resolved prior therapy toxicities to Grade 1 or stable Grade 2, except alopecia. Excludes those with uncontrolled diseases like heart issues or diabetes, active infections including HIV/Hepatitis B/C and COVID-19, recent immunosuppressive treatments or cancer therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients with advanced solid tumors are treated with CLN-617 alone and in combination with pembrolizumab to determine the safety and optimal dose
Dose Optimization
Patients receive selected doses of CLN-617 in combination with pembrolizumab to optimize dosing
Dose Expansion
Patients with advanced melanoma or head and neck squamous cell carcinoma are treated with CLN-617 in combination with pembrolizumab to expand the study population
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CLN-617
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cullinan Therapeutics Inc.
Lead Sponsor
Cullinan Oncology, LLC
Lead Sponsor
Cullinan Oncology Inc.
Lead Sponsor