CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this protocol is to investigate the efficacy of the combination of CB-839 with Niraparib in platinum resistant BRCA wild-type ovarian cancer patients. The primary and secondary objectives are to determine the maximum tolerated dose of CB-839 in combination with Niraparib and to determine the response rate and percentage of participants who remain progression free at 6 months.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Niraparib

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

• Estimated life expectancy of at least 3 months

• Measurable disease; at least one tumor lesion/lymph node that meets the RECIST 1.1 criteria for measurability

• Negative serum or urine pregnancy test within 3 days prior to the first dose

• Serum creatinine <= 2.0 x upper limit of normal (ULN)

• Adequate hematological function

• Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <3.0 x ULN

• Total bilirubin <=1.5 x ULN

Exclusion Criteria:

• Prior treatment with CB-839 or a PARP inhibitor

• Receipt of any anticancer therapy within the following windows:

• Small molecule tyrosine kinase inhibitor therapy (including investigational) within 2 weeks or 5 half-lives, whichever is longer

• Any type of anti-cancer antibody within 4 weeks

• Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization

• Subjects with clinically relevant ongoing complications from prior radiation therapy

• Other investigational therapy within 2 weeks or 5 half-lives, whichever is longer

• Any other current or previous malignancy within he past three years except:

• Adequately treated basal cell or squamous cell skin cancer

• Carcinoma in situ of the cervix

• Prostate cancer with stable prostate specific antigen (PSA) levels for >3 years

• Other neoplasm that, in the opinion of the Principal Investigator, will not interfere with the study-specific endpoints