Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥18 years old with advanced or metastatic stage solid tumors
  2. Eastern Cooperative Oncology Group (ECOG) status ≤ 1 and measurable disease per RECIST V1.1 (except for patients in dose escalation and prostate cancer patients)
  3. 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.

Exclusion Criteria

All patients

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (Dose Escalation)
Approximately 25 subjects to receive continuous BGB-290 and TMZ (Days 1 - 7 of 28 day cycle).
  • Drug: BGB-290
    BGB-290
  • Drug: Temozolomide
    TMZ
    Other names:
    • TMZ
Experimental
Arm B (Dose Escalation)
Approximately 25 subjects to receive continuous BGB-290 and continuous TMZ (28-day cycle).
  • Drug: BGB-290
    BGB-290
  • Drug: Temozolomide
    TMZ
    Other names:
    • TMZ
Experimental
Arm C (Dose Expansion)
Approximately 100 subjects to receive BGB-290 and TMZ.
  • Drug: BGB-290
    Dose/schedule selected based on dose escalation phase.
  • Drug: Temozolomide
    Dose/schedule selected based on dose escalation phase.
    Other names:
    • TMZ

Recruiting Locations

Montefiore Medical Center PRIME
New York, New York 10461

More Details

Status
Recruiting
Sponsor
BeiGene

Study Contact

BeiGene
1 (877) 828-5568
clinicaltrials@beigene.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.