A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Recruiting now · Phase 1

Conditions studied: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma, Malignant Melanoma

In brief

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.

Key facts

Study ID: NCT06150664
Run by: Compass Therapeutics
People needed: 85
Starts: 2024-03-19
Expected to finish: 2027-05-01
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 years or older
Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including
Malignant Melanoma (MM)
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
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
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
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
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
(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
(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)

You may not qualify if…

Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment
Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed
Patient is a pregnant or lactating WOCBP
Prior organ transplantation
Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.
Active autoimmune disease or medical conditions requiring chronic steroid (i.e., > 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor
History of primary malignancy other than the malignancy under study will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.
Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.
Other medical condition that in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:
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

Where it is running

Summit Cancer Center — Spokane, Washington, United States (enrolling)
Florida Cancer Specialists - Lake Nona — Orlando, Florida, United States (enrolling)
Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States (enrolling)
University Cancer & Blood Center — Athens, Georgia, United States (enrolling)
Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (enrolling)
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
D&H Cancer Research Center — Margate, Florida, United States

Full record on ClinicalTrials.gov

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