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
The primary objective of this study is to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.
- 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 participants in dose escalation and prostate cancer participants)
- Additional inclusion criteria for dose expansion cohorts:
Participants 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. Participants 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).
Participants 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. Participants Small cell lung and gastric cancer
a. Previously received ≤ 2 prior lines of therapy. Participants with HRD+ NSCLC, head and neck cancer, esophageal cancer and soft tissue sarcomas
1. Must have tumors with with HRD+ as centrally determined
2. Must have received at least 1 but not more than 3 prior lines of therapy.
Treatment naïve patients with soft tissue sarcoma might be allowed if standard of care therapy is not suitable or available.
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) TMZ Pulse Dosing
|Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 7 of a 28-day cycle.||
Arm B (Dose Escalation) TMZ Continuous Dosing
|Participants receive continuous BGB-290 and escalating flat doses of 40mg, 80mg, 100mg, 120mg (as 20 mg capsules) daily administered orally up to the maximum tolerated dose (MTD) of TMZ on Days 1 - 28 of a 28-day cycle.||
Dose Expansion, 6 cohorts
|Participants receive continuous BGB-290 and TMZ at the recommended phase 2 dose (RP2D) and schedule in 28 day cycles||
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