InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 30 January 2024

BGB-290-103: This phase I/II trial is evaluating a new drug (BGB-290) in combination with an oral chemotherapy drug (Temozolomide) in patients with locally advanced or metastatic solid cancersA 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

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 patients with advanced solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 99

Phase

I/II

Trial Acronym

BGB-290-103

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

Eligibility

Inclusion

  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 participants in dose escalation and prostate cancer participants)
  3. 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.

Exclusion

  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.

Inclusion

  • Your cancer has spread to other parts of the body.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.