Actively Recruiting
CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Led by Cullinan Therapeutics Inc. · Updated on 2025-03-03
86
Participants Needed
5
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Previously received or have contraindications to standard therapies that improve survival
- Confirmed advanced or metastatic non-neurological solid tumor with injectable lesions for dose escalation phase
- Confirmed select advanced cancers with injectable lesions for dose optimization phase
- Confirmed metastatic or locally advanced, unresectable melanoma or head and neck squamous cell carcinoma with injectable lesions for dose expansion phase
- Have measurable tumors per RECIST v1.1 and tumors that can be palpated, visualized by ultrasound, and safely injected
- Suitable for pembrolizumab treatment based on tumor type and prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Prior treatment toxicities resolved to Grade 1 or less, except stable chronic Grade 2 toxicities with agreement
- Adequate liver, kidney, and blood function based on specified laboratory values
- Agree to provide fresh biopsies at baseline and during treatment as required by study phase
You will not qualify if you...
- Presence of second cancers unless treated and in remission for at least 2 years without need for further therapy
- Active or history of autoimmune disease requiring systemic corticosteroids or immunosuppressants, except certain stable conditions
- Serious uncontrolled medical conditions including uncontrolled airway issues, diabetes type 1, pulmonary disease, heart failure, abnormal heart rhythms, uncontrolled hypertension, recent stroke, seizure disorders, or recent diverticulitis
- Use of systemic anticoagulation or bleeding disorders
- Recent treatment with systemic antiviral, antibacterial, or antifungal agents for acute infection
- HIV infection with low CD4 counts, recent antiretroviral use, or high viral load
- Active hepatitis B or C infection with detectable virus or recent antiviral therapy
- History of organ transplant or hematopoietic stem cell transplantation
- Active brain metastases or carcinomatous meningitis unless treated and stable
- Active COVID-19 infection or pending SARS-CoV-2 test results
- Recent use of immunosuppressive medications or systemic anticancer treatments, radiotherapy, or major surgery within specified timeframes
- Women who are pregnant, breastfeeding, planning pregnancy, or not using effective birth control
- Men planning to father a child or donate sperm without using effective birth control measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Not Yet Recruiting
2
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
5
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Shane McLoughlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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