CTX-8371 for Advanced Cancers
This study is testing a new treatment called CTX-8371 for people with advanced cancers like Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, and Malignant Melanoma. CTX-8371 is given through an IV (intravenous) every two weeks. This is a "first-in-human" study, meaning it's the first time this drug is being given to people. Researchers want to find out if CTX-8371 is safe and what dose works best. You might be able to join if you are 18 or older and your cancer has not responded to standard treatments or if there are no other effective treatments available. The study is currently unclear on its recruitment status and plans to enroll 85 participants.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving CTX-8371. It will enroll 85 participants and has two parts: dose escalation to find the right dose, and dose expansion to further evaluate that dose.
- What's involved
- You would receive CTX-8371 as an IV infusion every two weeks. The study will monitor your safety and tolerability from your first dose until 30 days after your last dose, which could be an average of 6 months or up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 30 days after your last dose of CTX-8371. This monitoring period could last an average of 6 months or up to 2 years, depending on the study cohort.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06150664
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentCompass Therapeutics
~85 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:CTX-8371
At a glance
Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371
Measured over From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371, average of 6 months
+2 more outcomes measured
Conditions
Where it's being run
10 sites across 7 statesFlorida3
Massachusetts2
Georgia1
Indiana1
New York1
Tennessee1
Washington1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor
Uveal and mucosal melanoma are excluded 2. Head and Neck squamous cell carcinoma (HNSCC)
HNSCC of oral cavity, oropharynx, hypopharynx, or larynx
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have received prior treatment with platinum-based chemotherapy 3. Non-Small Cell Lung Cancer (NSCLC)
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody
Patients must have received prior treatment with platinum-based chemotherapy 4. Triple Negative Breast Cancer (TNBC)
ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)
Patients with HER2-low cancers (HER2 IHC 1+ or 2+/ISH negative) are excluded
Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy 5. Classical Hodgkin Lymphoma (HL)
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor
Patients must have experienced less than a CR (according to Lugano criteria) to anti- PD-1 treatment 6. (Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)
Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment
Patients must have received prior treatment with platinum-based chemotherapy 7. (Cohort 2 Dose Expansion) Triple Negative Breast Cancer (TNBC)
ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)
Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy
Patients with HER2-low tumors (HER2 IHC 1+ or 2+/ISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu) 8. (Cohort 2 Dose Expansion) Classical Hodgkin's Lymphoma (HL)
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor.
Patients must have received at least 12 weeks of treatment with a PD-1/PD-L1 inhibitor as a monotherapy or in combination and had at least stable disease or progressive disease (PD) with overall clinical benefit. 3. Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion \> 1.5 cm for nodal, \> 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion)
Exclusion
Congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias
QTc interval (using Fridericia correction calculation) \> 480 msec
What this trial measures
- Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371, average of 6 months
Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities
- Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studiesFrom first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-8371 (average of 6 months )
- Cohort 2: Evaluate the safety and tolerability of CTX-8371 at 3.0 mg/kg and 10.0 mg/kgFrom first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371 (up to 2 years)
Incidence of treatment-emergent adverse events (TEAEs)