Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
This study is to evaluate the safety, efficacy and clinical activity of BGB-290 and temozolomide (TMZ) in participants with locally advanced or metastatic solid tumors.
- Locally Advanced or Metastatic Solid Tumors
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥18 years old with advanced or metastatic stage solid tumors
- Eastern Cooperative Oncology Group (ECOG) status ≤ 1 and measurable disease per RECIST V1.1 (except for patients in dose escalation and prostate cancer patients)
- Additional inclusion criteria for dose expansion cohorts:
Patients with homologous recombination deficiency (HRD+) or known BRCA mutant Ovarian cancer
a. Previously received at least 1 line of platinum containing chemotherapy and No progression or recurrent disease in 6 months from last platinum containing regimen. Patients with HRD+ or known breast cancer susceptibility gene (BRCA) mutant Triple-Negative Breast Cancer
a. 0 - 1 prior platinum-containing regimen (any treatment setting) and received ≤ 3 prior regimens (advanced or metastatic setting).
Patients with HRD+ or known BRCA mutant Prostate cancer
1. Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
2. May have pre-or post-treatment with a novel androgen receptor targeted agent. Small cell lung and gastric cancer
a. Previously received ≤ 2 prior lines of therapy.
1. Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
2. Refractory to platinum-based therapy.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Arm A (Dose Escalation)
|Approximately 25 subjects to receive continuous BGB-290 and TMZ (Days 1 - 7 of 28 day cycle).||
Arm B (Dose Escalation)
|Approximately 25 subjects to receive continuous BGB-290 and continuous TMZ (28-day cycle).||
Arm C (Dose Expansion)
|Approximately 100 subjects to receive BGB-290 and TMZ.||
1 (877) 828-5568
This is an open-label study of BGB‑290 and temozolomide (TMZ) with a dose escalation and dose expansion phase. Dose escalation will evaluate safety, tolerability, preliminary efficacy, and PK and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for the two drug combination. It is a modified 3+3 dose escalation scheme with a fixed dose of BGB‑290 in combination with escalating doses of TMZ. Dose expansion will evaluate the safety, PK profile and anti-tumor activity of BGB-290 and TMZ at a dose/schedule selected from the dose escalation phase. Five different solid malignancy types (n=100) will be evaluated.