NCT06576037

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Objectives: To determine the safety and tolerability of CBP-1019 combinations (Regimen A: CBP-1019 plus FOLFOX; Regimen B: CBP-1019 plus FOLFOX with bevacizumab; Regimen C: CBP-1019 plus pembrolizumab; and Regimen D: CBP-1019 plus enzalutamide) in metastatic solid tumors of epithelial origin. To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin. Secondary Objective: To evaluate other indicators of the antitumor activity of CBP-1019 combinations. Exploratory Objectives: To explore potential biomarkers associated with response/resistance and major clinical outcomes (toxicity and antitumor activities) through molecular profiling at the DNA, RNA and protein levels. To explore patient-reported outcomes (PROs).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	CBP-1019	Given by vein (IV)
DRUG	Oxaliplatin	Given by vein (IV)
DRUG	Leucovorin	Given by vein (IV)
DRUG	5-FLUOROURACIL	Given by vein (IV)
DRUG	Bevacizumab	Given by vein (IV)
DRUG	Pembrolizumab	Given by vein (IV)
DRUG	Enzalutamide	Given by mouth

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-06-01
• Completion: 2029-06-01
• First posted: 2024-08-28
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study