Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Neoplasms

Sponsor
Compass Therapeutics
Study ID
NCT07684170
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTX-471 — DRUG
    Patients will receive CTX-471 as an intravenous (IV) infusion every 2 weeks until disease progression or unacceptable toxicity.

Study Details

This study will enroll patients with central lab confirmed NCAM (CD56 IHC) positive metastatic neuroendocrine neoplasms that have progressed after standard of care treatment. CTX-471 to be administered as an intravenous (IV) infusion at either 0.3 mg/kg or 0.6 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The study will be conducted in two stages. In Stage 1, 18 patients will be accrued for each dose level. If there are less than 2 objective responses in these 18 patients at either dose level, the dose level will be stopped. Otherwise, an additional 22 patients will be accrued in Stage 2 with 11 patients for each dose level.

Key Dates

First listed
Jul 6, 2026
Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0.3 mg/kg
  • Experimental: Dose Level 0.6 mg/kg

Primary Outcome Measure

Evaluate the clinical activity of CTX-471 [ Time Frame: Baseline until confirmed disease progression (up to 1 year) ]

Central Contacts

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