Actively Recruiting
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Led by Compass Therapeutics · Updated on 2026-04-20
85
Participants Needed
9
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.
CONDITIONS
Official Title
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of locally advanced unresectable or metastatic malignant melanoma, head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer, or classical Hodgkin lymphoma
- For malignant melanoma, progression after at least 2 doses of PD-1/PD-L1 therapy and prior BRAF mutation testing
- For head and neck squamous cell carcinoma, progression after at least 2 doses of PD-1/PD-L1 therapy and prior platinum-based chemotherapy
- For non-small cell lung cancer, progression after at least 2 doses of PD-1/PD-L1 therapy and prior platinum-based chemotherapy
- For triple negative breast cancer, defined ER/PR and HER2 status, prior sacituzumab govitecan, and if PD-L1 ≥10% by CPS, pembrolizumab with chemotherapy
- For classical Hodgkin lymphoma, at least two prior systemic therapies including brentuximab vedotin and a prior PD-1 inhibitor, with less than complete response to PD-1 treatment
- Measurable disease per RECIST 1.1 for NSCLC, MM, TNBC, and HNSCC; measurable lesion per Lugano criteria for HL
- ECOG performance status 0-1
- Adequate bone marrow, liver, and kidney function
- Female patients must be surgically sterile, postmenopausal, or agree to use birth control; male patients must be sterile or agree to reliable birth control
- Negative pregnancy test for women of childbearing potential
- Last dose of prior PD-1/PD-L1 therapy at least 28 days before first CTX-8371 dose
- Resolution of prior anticancer therapy toxicities to ≤ Grade 2
- Life expectancy of at least 12 weeks
- Ability to understand and comply with study requirements
- Signed informed consent form before any study procedures
You will not qualify if you...
- History of serious adverse reactions to PD-1 or PD-L1 therapy leading to treatment discontinuation
- Use of systemic immunosuppressive therapy within 7 days before starting CTX-8371, except certain corticosteroids
- Pregnant or breastfeeding women of childbearing potential
- Prior organ transplantation
- Active infection with hepatitis B, hepatitis C, or HIV unless adequately controlled
- Active autoimmune diseases requiring chronic steroid or immunosuppressive treatment
- History of other primary malignancies with significant risk except those with high survival rates
- Symptomatic or uncontrolled brain metastases or leptomeningeal disease; stable brain metastases allowed
- Medical conditions that could interfere with participation or study interpretation, including significant heart disease or prolonged QTc interval >480 msec
AI-Screening
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Trial Site Locations
Total: 9 locations
1
D&H Cancer Research Center
Margate, Florida, United States, 33063
Withdrawn
2
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
3
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34236
Actively Recruiting
4
University Cancer & Blood Center
Athens, Georgia, United States, 30607
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
8
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
Summit Cancer Center
Spokane, Washington, United States, 99208
Actively Recruiting
Research Team
N
Natalie Warholic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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