RecruitingPhase 1

A Phase 1 Study of the Safety and Tolerability of CTX-10726

United States70 participantsStarted 2026-05-01

Plain-language summary

This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.

Who can participate

Age range18 Years

SexALL

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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:

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.
✕. Prior organ transplantation.
✕. History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.
✕. History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.
✕. Known, symptomatic central nervous system (CNS) and brain metastasis.
✕. A pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc).
✕. Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.
✕. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.

What they're measuring

Cohort 1: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) in escalating doses

Timeframe: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726, average of 6 months)

Cohort 1: Determine the dose(s) of CTX-10726 to be further examined in Cohort 2 and Phase 2 studies

Timeframe: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-10726 (average of 6 months)

Cohort 2: Evaluate the safety and tolerability of CTX-10726 by incidence of treatment-emergent adverse events (TEAEs) at dose(s) selected from Cohort 1

Timeframe: From first dose of CTX-10726 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-10726 (up to 2 years)

Trial details

NCT IDNCT07419841

SponsorCompass Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-01

Contact for this trial

Sarah Pilgrim

617-500-8099 ctx-10726-001@compasstherapeutics.com

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