Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin

Recruiting now · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT06576037

Run by

M.D. Anderson Cancer Center

People needed

128

Starts

2024-10-31

Expected to finish

2029-06-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• In the dose expansion, Regimen A will enroll patients with metastatic pancreatic cancer with concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 1), Regimen B will enroll patients with metastatic colorectal cancer concurrent oxaliplatin and irinotecan-free interval ≥4 months (Cohort 2), Regimen C will enroll patients with metastatic solid tumors of epithelial origin who have received prior anti-PD-(L)1 therapy (Cohort 3), and Regimen D will enroll patients with metastatic castration-resistant and taxane-treated prostate cancer (Cohort 4).
• Patients (with the exception of those with prostate cancer) must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥10 mm (≥1 cm) with computed tomography (CT) scan,PET-CT, magnetic resonance imaging (MRI) scan, or calipers by clinical exam.
• Note: Prostate cancer patients must meet ≥1 of the following Prostate Cancer Clinical Trials Working Group 3 criteria [95]:
• 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.
• Ability to understand and the willingness to sign a written informed consent document.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (Appendix 1).
• 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.
• CrCl = (140-age) × (weight/kg) x Fa / (72 × serum creatinine mg/dL). a where F= 0.85 for females and F=1 for males 9. Patients whose baseline pulse oximetry is at least 90% on room air.
• Fridericia's corrected QT interval (QTcF =QT/∛(60/HR) ) ≤460 ms for males and ≤480 ms for females on electrocardiogram (ECG) conducted at rest during screening.
• Note: Patients with an atrioventricular pacemaker or other condition (e.g., right bundle branch block) that renders the QT measurement invalid are an exception and this criterion does not apply.
• The effects of study drugs on the developing human fetus are unknown. For this reason and because Class II drugs as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, throughout the study treatment period, and for 6 months after study treatment completion (Refer to Pregnancy Assessment Policy MDACC Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).

You may not qualify if…

• Has received an investigational non-myelosuppressive agent within 14 days prior to study treatment initiation or an investigational myelosuppressive agent within 21 days prior to study treatment initiation.
• Uncontrolled intercurrent illness including but not limited to:
• 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.
• Note: Patients with a diagnosis of incidental subsegmental pulmonary embolism or deep vein thrombosis are allowed if stable, asymptomatic, and on a stable dose of anticoagulant for at least 1 week before the first dose of study treatment.
• Unresolved clinically significant Grade ≥1 toxicity from prior therapy. Note: Patients who were exposed to prior treatment with any of the combination regimens that experienced intolerable or severe toxicity, even if they recovered; or who required dose reduction of chemotherapy or enzalutamide in their standard of care therapies should be excluded.
• History of allergic reactions to the study drugs or any of their components.
• Has not recovered from a major surgical procedure or significant traumatic injury (i.e., still needing additional surgical or medical care for these issues): major surgical procedures ≤28 days prior to study entry or minor surgical procedures ≤7 days prior to study entry. No waiting period is required following port-a-cath or other central venous access placement. Patients must have complete wound healing from major or minor surgery before the first dose of study treatment.
• Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a therapeutic device for cancer control, then agreement with the investigator and the Sponsor is required to establish eligibility.
• Has received a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: Bacille Calmette-Guérin vaccine, measles, mumps, rabies, rubella, typhoid vaccine, varicella/zoster, and yellow fever. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed. COVID-19 vaccines including killed virus are allowed.
• Symptomatic primary tumors or metastasis in the brain and/or central nervous system (CNS) that are uncontrolled with antiepileptics and/or require prednisone >10 mg/day or equivalent.
• Note: Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, new, or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of study treatment.
• Evidence of leptomeningeal or lymphangitic carcinomatosis.
• Patients with a history of stem cell or solid organ transplantation.
• Breastfeeding or pregnant.
• Known history of positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
• Patients with a history of positive HIV test result who meet all the following eligibility criteria may be enrolled:

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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