RecruitingPhase 1NCT06150664

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

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies


Sponsor

Compass Therapeutics

Enrollment

85 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial is testing a new experimental cancer drug called CTX-8371 in people with advanced cancers that have not responded to prior immunotherapy. CTX-8371 is a new type of immune therapy that works differently from standard checkpoint inhibitors. The study is focused on several cancer types including melanoma, head and neck cancer, lung cancer, triple-negative breast cancer, and Hodgkin lymphoma. **You may be eligible if...** - You are 18 or older with advanced cancer (melanoma, head/neck squamous cell carcinoma, non-small cell lung cancer, triple-negative breast cancer, or classical Hodgkin lymphoma) that has not responded to prior treatment including immunotherapy - You have previously received at least 2 doses of a PD-1/PD-L1 inhibitor (a type of immunotherapy) and your cancer has progressed - You are in good health (ECOG 0–1) with adequate organ function - Your last immunotherapy was within 12 weeks of enrolling **You may NOT be eligible if...** - You had to permanently stop immunotherapy due to severe immune-related side effects - You have brain metastases (cancer that spread to the brain) - You have had a prior organ transplant - You have an active autoimmune disease requiring high-dose steroids - You have significant uncontrolled heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTX-8371

Intravenous (IV) infusion every two weeks.


Locations(9)

D&H Cancer Research Center

Margate, Florida, United States

Florida Cancer Specialists - Lake Nona

Orlando, Florida, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

University Cancer & Blood Center

Athens, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Tennessee Oncology

Nashville, Tennessee, United States

Summit Cancer Center

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06150664


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