Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06576037
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • CBP-1019 — DRUG
    Given by vein (IV)
  • Oxaliplatin — DRUG
    Given by vein (IV)
  • Leucovorin — DRUG
    Given by vein (IV)
  • 5-FLUOROURACIL — DRUG
    Given by vein (IV)
  • Bevacizumab — DRUG
    Given by vein (IV)
  • Pembrolizumab — DRUG
    Given by vein (IV)
  • Enzalutamide — DRUG
    Given by mouth

Study Details

An open-label, Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin.

Key Dates

Start date
Oct 31, 2024
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2029

Study Design

Enrollment
128 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: Dose Escalation CBP-1019 + FOLFOX
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 1C: Dose Escalation CBP-1019 + Pembrolizumab
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 1D: Dose Escalation CBP-1019 + Enzalutamide
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 2A: Pancreatic CBP-1019 + FOLFOX
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab
    Participants will be administered the study treatments on an outpatient basis.
  • Experimental: Part 2D: CRPC CBP-1019 + Enzalutamide
    Participants will be administered the study treatments on an outpatient basis.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Siqing Fu, MD,PHD
[email protected]
713-792-4318
Siqing Fu, MD,PHD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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