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

Part of paid clinical trials in Margate, Florida.

Sponsor
Compass Therapeutics
Study ID
NCT06150664
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • CTX-8371 — DRUG
    Intravenous (IV) infusion every two weeks.

Study Details

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 Dates

Start date
Mar 19, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
85 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort 1
    Escalating doses of CTX-8371
  • Experimental: Dose Expansion Cohort 2
    Two CTX-8371 dose groups (3.0 mg/kg and 10.0 mg/kg) in three tumor type subgroups (NSCLC, TNBC, and HL)

Primary Outcome Measure

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371 [ Time Frame: 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 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
D&H Cancer Research CenterMargateFlorida33063-
Florida Cancer Specialists - Lake NonaOrlandoFlorida32827
Elizabeth Gilmore
[email protected]
904-380-2410
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists - SarasotaSarasotaFlorida34236
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
University Cancer & Blood CenterAthensGeorgia30607
Pope, RN, OCN, CCRC
[email protected]
706-353-2990
Frederick Flynt, MD, FACP (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Susan Gotthardt, RN
[email protected]
Hollis Viray, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kailene Sullivan, RN
[email protected]
617-632-3482
Patrick Ott, MD, PhD (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
ASKRPCI
[email protected]
800-767-9355
Benjamin Switzer, DO (PRINCIPAL_INVESTIGATOR)
Tennessee OncologyNashvilleTennessee37203
Lauren Carey
[email protected]
Jeff Russell, MD (PRINCIPAL_INVESTIGATOR)
Summit Cancer CenterSpokaneWashington99208
Monika Chaudhry
[email protected]
509-462-2273 opt 7
Arvind Chaudhry, MD (PRINCIPAL_INVESTIGATOR)

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