Phase Ib Study of CBP-1019 for Metastatic Solid Tumors
This study is testing a new drug called CBP-1019 in combination with other common cancer treatments like FOLFOX (a chemotherapy combination of Oxaliplatin, Leucovorin, and 5-FLUOROURACIL), Bevacizumab, Pembrolizumab, or Enzalutamide. It's for people with metastatic (spread to other parts of the body) solid tumors of epithelial origin (cancers that start in the lining of organs) that have not responded to standard treatments. The main goal is to see how safe these combinations are and what side effects they might cause. Researchers will also look at how well these combinations shrink tumors. You may be able to join if you are 18 or older and have a solid tumor that has spread or cannot be removed by surgery, and you have already tried at least one other treatment.
- Study design
- This is an open-label, Phase Ib study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 128 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and side effects will be monitored through study completion, which is expected to be an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06576037
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~128 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:CBP-1019OxaliplatinLeucovorin5-FLUOROURACILBevacizumabPembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Siqing Fu, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Progression in measurable disease.
Bone disease progression defined by the appearance of ≥2 new bone lesions.
Prostate-specific antigen (PSA) progression defined as ≥2 sequential rises in PSA obtained ≥1 week apart with a minimal starting value of ≥1 ng/mL. A PSA value ≥2 ng/mL is required at study entry. 4. Ability to understand and the willingness to sign a written informed consent document. 5. Age ≥18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (Appendix 1). 7. Must have adequate organ and marrow functions as defined below:
Absolute neutrophil count (ANC) ≥1.5× 109/L: growth factor support is not allowed within 2 weeks of study treatment initiation.
Hemoglobin ≥9 g/dL: packed RBC transfusion is allowed as long as there is no active bleeding.
Platelets ≥100× 109/L: transfusion is not allowed within 2 weeks of study treatment initiation.
Total bilirubin ≤1.5× upper limit of normal (ULN); or total bilirubin \<3.0× ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert's syndrome.
Alanine aminotransferase (ALT) and AST ≤2.5× the upper limit of the reference range, or ≤ 5× the upper limit of the reference range for patients with liver metastases.
Serum albumin ≥3 g/dL.
Urinalysis ≤1 proteinuria, or urine protein/creatinine ratio (UPCR) ≤1 mg/mg (≤113.2 mg/mmol), or 24-h urine protein ≤1 g (applies to bevacizumab-based regimen only).
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× ULN if not on therapeutic anticoagulation.
Calculated creatinine clearance (CrCl) ≥50 mL/min by the Cockcroft-Gault method as below or 24-hour urine collection.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Agree to provide baseline tumor specimens: archival tissue block, or 10 FFPE slides, or a pre-treatment biopsy.
Patients must have adequate washout from prior therapy at the time of study treatment initiation: 3 weeks from any treatment specifically for systemic tumor control; 2 weeks from cytotoxic agents that were administered weekly; 6 weeks from nitrosoureas or mitomycin C; and 5 half-lives from targeted agents with half-lives and pharmacodynamic effects lasting \<5 days.
Exclusion
Ongoing or active infection requiring IV antibiotics.
Symptomatic congestive heart failure (New York Heart Association Class III or IV).
History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months before study enrollment.
Lesions invading or encasing any major blood vessels and cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation; uncontrolled hypertension defined as sustained blood pressure \>140 mmHg systolic / \>90 mmHg diastolic despite optimal antihypertensive treatment (applies to bevacizumab-based regimen only).
History or current evidence of uncontrolled ventricular arrhythmia.
Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death.
Clinically significant bleeding or active gastric or duodenal ulcer.
Chronic diarrhea disease considered to be clinically significant by the investigator.
Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the first dose of study treatment, or any GI disorders associated with a high risk of perforation or fistula formation.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Have a T cell (CD4+) count ≥350 cells/μL.
No history of opportunistic infections or other malignancies.
Have an HIV viral load less than 400 copies/mL.
In the opinion of the investigator, their antiretroviral therapy or other HIV treatments will not interfere with the activity of the investigational product or cause any confusion with the assessment of the investigational drug toxicities.
Negative viral load test (HBV DNA or HCV RNA) at screening. 13. Ability to take oral medications without medical history of malabsorption or other chronic GI disease, or other conditions that may hamper compliance and/or absorption of the study agent (applies to enzalutamide-based regimen only). 14. Concurrent immunosuppressive therapy or steroid therapy (\>10 mg/day prednisone or equivalent) (applies to pembrolizumab-based regimen only). 15. History of autoimmune disease including but not limited to inflammatory bowel disease, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis that required systemic therapy in the past 2 years (applies to pembrolizumab-based regimen only).
What this trial measures
- 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