Clinical trial · Interventional
CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients
Phase 1 Trial of CB-839 in Combination With Niraparib in Platinum Resistant BRCA-wild-type Ovarian Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): will not resume. company choosing not to continue with drug. one participant now off study.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Resistant BRCA Wild-Type Ovarian Cancer | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort 1: Dose Escalation | Drug | — | UNRESOLVED |
| Cohort 2: Dose Escalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1: Dose Escalation using Niraparib and CB-839
- description
- The first phase will be a 3+3 design, 3 participants will be enrolled in the first cohort with a fixed dose of Niraparib and CB-839, 600 mg. If there are no dose limiting toxicities (DLT), 3 additional participants will be enrolled in the next cohort (CB-839, 800mg). If 1 of the 3 in the first cohort experiences DLT's, then the additional participants will be enrolled in the same cohort (CB-839, 600mg).
- interventionNames
- Drug: Cohort 1: Dose Escalation
- type
- EXPERIMENTAL
- label
- Cohort 2: Dose Escalation using Niraparib and CB-839
- description
- If there are no DLT's, 3 additional participants will be enrolled in the next cohort with a fixed dose of Niraparib and CB-839, 800mg.
- interventionNames
- Drug: Cohort 2: Dose Escalation
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available