Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18 - 99
Clinical summary
Summary
This is a non-randomised dose escalation and expansion study. Patients will be assigned to one of three arms. In Arm A (Dose Escalation) approximately 25 patients will receive continuous BGB-290 and TMZ on Days 1-7 of a 28 day cycle. In Arm B (Dose Escalation) approximately 25 patients will receive continuous BGB-290 and continuous TMZ on a 28 day cycle. In Arm C (Dose Expansion) approximately 100 patients will receive BGB-290 and TMZ at the recommended dose from the escalation phase.
Conditions
This trial is treating people with advanced solid cancers
Eligibility
Inclusion
- 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
- Chemotherapy-naïve or previously received ≤2 taxane-based regimens.
- 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
- Must have tumors with with HRD+ as centrally determined
- 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.
Exclusion
- Prior exposure to a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor.
- Refractory to platinum-based therapy.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene USA, Inc.
Scientific Title
A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors
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