Clinical trialPhase 1Recruiting
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 31 October 2024
- Expected end
- 1 June 2029
- Enrollment
- 128 participants
- Sites
- 1
- Primary outcomes
- Safety and Adverse Events (AEs)
- Sponsor
- Other
- Results posted
- No
- Last update
- 1 September 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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).