Clinical trial · Interventional
Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer
Phase I Study to Evaluate the Tolerability, Safety and Efficacy of BMN-673 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumor Malignancies That Have BRCA Mutations or Triple Negative Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding support for the study was terminated
Summary
Brief summary (as posted)
Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the safety of the combination of BMN 673 and carboplatin, and subsequently BMN 673 in combination with paclitaxel and carboplatin to determine the recommended Phase II dose of the combination.
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 |
|---|---|---|---|
| BRCA-mutated Solid Tumor | — | UNRESOLVED | — |
| Triple Negative Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMN-673 | Drug | Talazoparib | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- BMN-673: Oral, every day, Days 1-21; Carboplatin: intravenous, every week, 750 μg/day; Paclitaxel: intravenous, every week, 0.75 x Maximum Tolerated Dose μg/day
- interventionNames
- Drug: BMN-673
- Drug: Carboplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From date of randomization until the date of Initial response to the first documented tumor progression or date of death from any cause, up to 18 months.
- description
- Response rate of combination (BMN 673 + carboplatin) in patients with BRCA germline mutations or triple negative cancer without known BRCA mutations, in solid tumor malignancies with paclitaxel with a 15 patient cohort expansion at the maximum tolerated dose (MTD). Response and progression in this study will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, 18 years or older with advanced malignancies for which no standard therapy is available. * Dose Escalation: Patients with any solid tumor malignancies * Does Expansion: * Patients with advanced malignancies that have germline and/or somatic BRCA mutations (cohort gBRCA) Or * Triple negative (TN) metastatic breast cancer without known BRCA mutation (cohort TNBC). Tumors will be considered TN when: * Estrogen receptor (ER) expression \<1% * Progesterone receptor (PR) expression \<1% * Her2 negative as per the American Society of Clinical Oncology (ASCO) guidelines * Paclitaxel expansion: any solid tumor malignancy with potential benefit from this combination and paclitaxel (ASP). * Dose expansion cohort only: Histological or cytological confirmation of advanced unresectable solid tumors for which no standard therapy is available in patients with a known BRCA germline mutation or those with metastatic triple negative breast cancer without known BRCA mutation (see inclusion criteria one for definition of triple negative breast cancer).. For the paclitaxel cohorts, any solid tumors with potential benefit from this combination and paclitaxel. * Consent to screening tumor biopsy (for accessible tumors when appropriate) \[optional in dose escalation, mandatory in dose expansion\] * Part 2 only: Measureable tumor (RECIST1.1) * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. * Adequate organ function: * Absolute neutrophil count (ANC) ≥ 1.5 X 109/L * Hemoglobin (Hgb) ≥9.5 g/dL(transfusion before treatment is allowable if more than 3 days prior to study start) * Platelets (plt) ≥ 100 x 109/L * Potassium within normal range, or correctable with supplements; * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x Upper Limit Normal (ULN) * Serum total bilirubin ≤ 1.5 x ULN * Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 60ml/min * Females of child-bearing potential (FCBP) must have negative serum pregnancy test within 7 days before starting study treatment and willingness to adhere to acceptable forms of birth control (a physician-approved contraceptive method: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) for a minimum of 4 weeks following the discontinuation of study treatment. FCBP is defined as a sexually mature woman who: * Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or, * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time during the preceding 12 consecutive months * Male subjects with female partner of childbearing potential must agree to the use of a physician-approved contraceptive method throughout the course of the study and for a minimum of 4 weeks following the discontinuation of study treatment. * Ability to take oral medications Exclusion Criteria: * Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks, whichever is shorter, prior to starting study treatment * Patients must have recovered from side effects from prior cancer-directed therapy to grade 1 or less (unless deemed not clinically significant by study investigator). * Major surgery ≤ 4 weeks prior to starting study regimen or who have not recovered from surgery. * Any known unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure. * History of myocardial infraction (MI) within 6 month prior to starting study treatment. * Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. * Any condition that confounds the ability to interpret data from the study. * Symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 4 weeks are allowed. * Malabsorption or uncontrolled peptic ulcer disease * Grade 2 or higher peripheral neuropathy (paclitaxel arm only) * Known allergic reaction or poor tolerability to PARP inhibitors, carboplatin, or paclitaxel * Pregnant or breastfeeding * Known active human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
References
Publications (0)
Data not yet available