OncoMatch/Clinical Trials/NCT06150664
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Is NCT06150664 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies CTX-8371 for non small cell lung cancer.
Treatment: CTX-8371 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Hodgkin Lymphoma
Head and Neck Squamous Cell Carcinoma
Melanoma
Biomarker criteria
Excluded: HER2 (ERBB2) low expression
Patients with HER2-low cancers (HER2 IHC 1+ or 2+/ISH negative) are excluded
Allowed: BRAF v600 activating mutation
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — Malignant Melanoma
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
Must have received: BRAF inhibitor — Malignant Melanoma with BRAF V600 activating mutation
Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor
Must have received: anti-PD-1 therapy — Head and Neck Squamous Cell Carcinoma
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
Must have received: platinum-based chemotherapy — Head and Neck Squamous Cell Carcinoma
Patients must have received prior treatment with platinum-based chemotherapy
Must have received: anti-PD-1 therapy — Non-Small Cell Lung Cancer
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
Must have received: platinum-based chemotherapy — Non-Small Cell Lung Cancer
Patients must have received prior treatment with platinum-based chemotherapy
Must have received: anti-PD-1 therapy — Triple-Negative Breast Cancer
if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy
Must have received: antibody-drug conjugate (sacituzumab govitecan) — Triple-Negative Breast Cancer
Patients must have received prior sacituzumab govitecan
Must have received: antibody-drug conjugate (fam-trastuzumab deruxtecan) — Triple-Negative Breast Cancer, HER2-low tumors
Patients with HER2-low tumors (HER2 IHC 1+ or 2+/ISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu)
Must have received: anti-PD-1 therapy — Hodgkin Lymphoma
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor
Must have received: antibody-drug conjugate (brentuximab vedotin) — Hodgkin Lymphoma (if eligible)
Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor
Lab requirements
Blood counts
absolute neutrophil (ANC) of ≥ 1.5×10^9/L, platelet count of ≥ 100.0×10^9/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion); blood transfusion not allowed within 2 weeks from the first dose of CTX-8371
Kidney function
creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation
Liver function
serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
Cardiac function
QTc interval (using Fridericia correction calculation) ≤ 480 msec; no congestive heart failure (> NYHA 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
Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×10^9/L, platelet count of ≥ 100.0×10^9/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion); Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases); Adequate renal function defined as creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation; QTc interval (using Fridericia correction calculation) ≤ 480 msec; no congestive heart failure (> NYHA 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- D&H Cancer Research Center · Margate, Florida
- Florida Cancer Specialists - Lake Nona · Orlando, Florida
- Florida Cancer Specialists - Sarasota · Sarasota, Florida
- University Cancer & Blood Center · Athens, Georgia
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06150664 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-PD-1 therapy and BRAF inhibitor.
Are patients with ERBB2 alterations eligible?
No. ERBB2 low expression is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify