RecruitingPhase 1

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

United States85 participantsStarted 2024-03-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)
. Head and Neck squamous cell carcinoma (HNSCC)
. Non-Small Cell Lung Cancer (NSCLC)
. Triple Negative Breast Cancer (TNBC)
. Classical Hodgkin Lymphoma (HL)
. (Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371

Timeframe: 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

Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studies

Timeframe: 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 )

Cohort 2: Evaluate the safety and tolerability of CTX-8371 at 3.0 mg/kg and 10.0 mg/kg

Timeframe: From 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)

Trial details

NCT IDNCT06150664

SponsorCompass Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Natalie Warholic

617-500-8099 CTX-8371-001@compasstherapeutics.com

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials