Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Phase 1
Recruiting
- Conditions
- Interventions
- Registration Number
- NCT06576037
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief 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.
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Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1A: Dose Escalation CBP-1019 + FOLFOX CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab Leucovorin Participants will be administered the study treatments on an outpatient basis. Part 1C: Dose Escalation CBP-1019 + Pembrolizumab CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 1C: Dose Escalation CBP-1019 + Pembrolizumab Pembrolizumab Participants will be administered the study treatments on an outpatient basis. Part 1D: Dose Escalation CBP-1019 + Enzalutamide CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 2A: Pancreatic CBP-1019 + FOLFOX CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 2D: CRPC CBP-1019 + Enzalutamide CBP-1019 Participants will be administered the study treatments on an outpatient basis. Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab Bevacizumab Participants will be administered the study treatments on an outpatient basis. Part 2A: Pancreatic CBP-1019 + FOLFOX Leucovorin Participants will be administered the study treatments on an outpatient basis. Part 1A: Dose Escalation CBP-1019 + FOLFOX Leucovorin Participants will be administered the study treatments on an outpatient basis. Part 1A: Dose Escalation CBP-1019 + FOLFOX Oxaliplatin Participants will be administered the study treatments on an outpatient basis. Part 1A: Dose Escalation CBP-1019 + FOLFOX 5-FLUOROURACIL Participants will be administered the study treatments on an outpatient basis. Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab Oxaliplatin Participants will be administered the study treatments on an outpatient basis. Part 1B: Dose Escalation CBP-1019 + FOLFOX + Bevacizumab 5-FLUOROURACIL Participants will be administered the study treatments on an outpatient basis. Part 1D: Dose Escalation CBP-1019 + Enzalutamide Enzalutamide Participants will be administered the study treatments on an outpatient basis. Part 2A: Pancreatic CBP-1019 + FOLFOX Oxaliplatin Participants will be administered the study treatments on an outpatient basis. Part 2A: Pancreatic CBP-1019 + FOLFOX 5-FLUOROURACIL Participants will be administered the study treatments on an outpatient basis. Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab Leucovorin Participants will be administered the study treatments on an outpatient basis. Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab Oxaliplatin Participants will be administered the study treatments on an outpatient basis. Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab 5-FLUOROURACIL Participants will be administered the study treatments on an outpatient basis. Part 2B: Colorectal CBP-1019 + FOLFOX + Bevacizumab Bevacizumab Participants will be administered the study treatments on an outpatient basis. Part 2C: Epithelial Origin CBP-1019 + Pembrolizumab Pembrolizumab Participants will be administered the study treatments on an outpatient basis. Part 2D: CRPC CBP-1019 + Enzalutamide Enzalutamide Participants will be administered the study treatments on an outpatient basis.
- Primary Outcome Measures
Name Time Method Safety and Adverse Events (AEs) Through study completion; an average of 1 year Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States