Actively Recruiting
A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies
Led by Compass Therapeutics · Updated on 2026-04-20
85
Participants Needed
9
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CTX-8371 in a Phase 1, open-label study involving patients with advanced cancers that are metastatic or locally advanced and have not responded to standard treatments. The study aims to assess the safety, tolerability, immune response, and how the body processes CTX-8371, as well as its preliminary anti-tumor effects. The research is organized into two groups: Dose Escalation and Dose Expansion cohorts. In the Dose Escalation group, patients receive increasing doses of CTX-8371 through intravenous infusions every two weeks, with doses ranging from 0.1 to 10.0 mg/kg. The Dose Expansion group receives fixed doses of either 3.0 mg/kg or 10.0 mg/kg, also administered intravenously every two weeks. Different tumor types such as non-small cell lung cancer, triple-negative breast cancer, and Hodgkin lymphoma are included in the Dose Expansion group. Participants will undergo regular safety and response evaluations including blood tests, imaging, and physical exams over an average follow-up of six months to two years depending on cohort. Researchers monitor tumor response, survival, and how the drug is processed in the body. Safety is tracked from the first dose until 30 days after the last dose. Participants will be closely followed for side effects, immune response, and treatment effects throughout the study period.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed locally advanced unresectable or metastatic malignancy relapsed/refractory to standard therapy or with no effective standard therapy
- Malignant melanoma patients must have progressed after at least 2 doses of PD-1/PD-L1 therapy and prior testing for BRAF V600 mutations; uveal and mucosal melanoma excluded
- Head and neck squamous cell carcinoma patients must have progressed after at least 2 doses of PD-1/PD-L1 therapy and prior platinum-based chemotherapy
- Non-small cell lung cancer patients must have progressed after at least 2 doses of PD-1/PD-L1 therapy and prior platinum-based chemotherapy
- Triple negative breast cancer patients must have defined ER/PR and HER2 status, prior sacituzumab govitecan, and if PD-L1 ≥10% by CPS, pembrolizumab with chemotherapy; HER2-low cancers excluded
- Classical Hodgkin lymphoma patients must have received at least two prior systemic therapies including brentuximab vedotin and prior PD-1 inhibitor, with less than complete response to PD-1 treatment
- Measurable disease per RECIST 1.1 for NSCLC, MM, TNBC, HNSCC; measurable lesion criteria per Lugano 2014 for HL
- ECOG performance status 0-1
- Adequate bone marrow, hepatic, and renal function as specified
- Female patients must use acceptable birth control or be surgically sterile/postmenopausal; males must use reliable contraception
- Negative pregnancy test for women of childbearing potential
- Last dose of prior PD-1/PD-L1 therapy ≥28 days, other anticancer therapy >21 days prior to first CTX-8371 dose
- Resolution of prior anticancer therapy toxicities to ≤ Grade 2
- Life expectancy ≥12 weeks
- Able to understand and comply with protocol requirements
- Signed informed consent form
You will not qualify if you...
- History of significant adverse reaction to PD-1/PD-L1 therapy leading to discontinuation
- Systemic immunosuppressive therapy within 7 days before CTX-8371 treatment, except certain corticosteroids
- Pregnant or lactating women of childbearing potential
- Prior organ transplantation
- Active hepatitis B, hepatitis C, or HIV infection unless adequately controlled and meeting liver function criteria
- Active autoimmune disease or requiring chronic steroid or immunosuppressive therapy
- History of other primary malignancy except low-risk cancers
- Symptomatic or uncontrolled central nervous system or brain metastases; asymptomatic stable brain metastases allowed
- Medical conditions interfering with study, including significant heart failure, coronary artery disease, unstable angina, or significant arrhythmias
- QTc interval >480 msec (Fridericia correction)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 2 years depending on cohort and treatment continuation
Participants receive CTX-8371 as an intravenous infusion once every 2 weeks at escalating doses or at fixed doses depending on cohort assignment.
Infusions every 2 weeks with assessment visits as scheduled during treatment
Duration - At least 30 days after the last dose of CTX-8371
Participants are monitored for safety, tolerability, and response after completing treatment with CTX-8371.
Follow-up visits as scheduled for safety assessments
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
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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