Part 1C: Dose Escalation CBP-1019 + Pembrolizumab for Solid Tumors

Phase 1

Waitlist Available

Led By Siqing Fu, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Patients must have histologically or cytologically confirmed malignancy of epithelial origin other than ovarian cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Patients must have received at least one prior line of systemic standard therapy, and have either disease progression or intolerable toxicity after standard treatment.

2. In the dose expansion, Regimen A will enroll patients with metastatic pancreatic cancer, Regimen B will enroll patients with metastatic colorectal cancer, Regimen C will enroll patients with metastatic solid tumors of epithelial origin who have received prior anti-PD-(L)1 therapy, and Regimen D will enroll patients with metastatic castration-resistant prostate cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

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.

Who is the study for?

This trial is for patients with solid tumors of epithelial origin that overexpress TRPV6. It's open to those who meet specific health criteria, but the details on eligibility are not provided here.

What is being tested?

The study tests CBP-1019 in combination with FOLFOX (a chemo regimen including Leucovorin, Oxaliplatin, and 5-FLUOROURACIL) and may add Bevacizumab, Pembrolizumab or Enzalutamide. The goal is to find safe doses and see how well these combinations work.

What are the potential side effects?

While specific side effects aren't listed here, common ones for chemotherapy like FOLFOX include nausea, fatigue, nerve damage; Bevacizumab can cause bleeding or hypertension; Pembrolizumab might lead to immune-related issues; Enzalutamide may result in seizures or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Adverse Events (AEs)