Actively Recruiting
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
128
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed metastatic or unresectable epithelial solid tumor (excluding ovarian cancer) with no effective standard curative or palliative treatments
- Have received at least one prior line of systemic standard therapy with disease progression or intolerable toxicity
- For dose expansion cohorts: specific tumor types and prior treatment intervals as defined per regimen
- Have measurable disease (except prostate cancer patients who must meet specific progression criteria)
- Be 18 years or older
- Have ECOG performance status of 0 or 1
- Have adequate organ and marrow function including specific blood counts, liver and kidney function, and proteinuria limits
- Have baseline pulse oximetry of at least 90% on room air
- Have acceptable QT interval on ECG
- Agree to use adequate contraception if of childbearing potential
- Have negative pregnancy test if female of childbearing potential
- Agree to provide baseline tumor specimens
- Have adequate washout from prior therapies as specified
You will not qualify if you...
- Received investigational non-myelosuppressive agent within 14 days or myelosuppressive agent within 21 days prior to study treatment
- Have uncontrolled illnesses such as active infections, severe heart conditions, uncontrolled hypertension (for bevacizumab regimen), or severe acute or chronic medical or psychiatric conditions
- Have unresolved significant toxicity from prior therapy
- History of allergic reactions to study drugs
- Not fully recovered from recent major or minor surgery
- Currently enrolled in incompatible clinical trials
- Received live vaccines within 30 days before treatment
- Have symptomatic or uncontrolled brain metastases or leptomeningeal carcinomatosis
- History of stem cell or solid organ transplantation
- Pregnant or breastfeeding
- Known positive for HIV, HBV, or HCV unless meeting specific criteria
- Unable to take oral medications or with malabsorption (for enzalutamide regimen)
- Receiving immunosuppressive or high-dose steroid therapy (for pembrolizumab regimen)
- History of autoimmune disease requiring systemic therapy in past 2 years (for pembrolizumab regimen)
- History of severe immune-related reactions or pneumonitis (for pembrolizumab regimen)
- History of severe allergic reactions to monoclonal antibodies (for bevacizumab or pembrolizumab regimens)
- History of severe neuropathy related to oxaliplatin (for FOLFOX regimens)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Siqing Fu, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
8
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