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Closed (no longer recruiting)Last updated: 23 January 2024

BeiGene 2: This phase I trial is evaluating a new drug known as BGB-290 in patients with solid cancersA Phase IA, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety and Pharmacokinetics of the PARP Inhibitor BGB-290 in Subjects With Solid Tumors

Clinical summary

Summary

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-290 in patients with solid tumors.

Conditions

This trial is treating patients with advanced cancers (excluding blood cancer).

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

Trial Acronym

BeiGene 2

More information

Trial Identifiers

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

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase IA, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety and Pharmacokinetics of the PARP Inhibitor BGB-290 in Subjects With Solid Tumors

Eligibility

Inclusion

  1. Male or female and at least 18 years of age with a life expectancy of at least 12 weeks.
  2. Histologically or cytologically confirmed malignancy that has progressed to the advanced or metastatic stage for which no effective standard therapy is available.
  3. BRCA1/2 mutations are not required but enrichment of this participant population is permitted.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  5. Adequate bone marrow, liver, and renal function.
  6. Participants who have histologic or cytologic confirmation of malignancy that has progressed to the advanced or metastatic stage.
  7. Eligible participants who have received the prior chemotherapy regimen in the advanced or metastatic setting.
  8. Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and throughout the study until 28 days after the last investigational product administration.
  9. Able to swallow and retain oral medication.

Exclusion

  1. Participants did not receive prior therapies targeting poly-ADP ribose polymerase (PARP).
  2. Participants who are not considered to be refractory to platinum-based therapy (e.g., progressive disease at the first tumor assessment while receiving platinum treatment).
  3. Participants who have not been treated with chemotherapy, biologic therapy, immunotherapy, or other investigational agent within five times half-lives of the last treatment or within 4 weeks (whichever is longer) prior to starting study drug (or who have not recovered from the side effects of such therapy).
  4. Participants who have not undergone major surgery/surgical therapy for any cause within 4 weeks of screening visit.
  5. Participants must have recovered from the treatment and have a stable clinical condition before entering this study.
  6. Participants who have not received therapeutic radiotherapy to target lesions. 7.Participants who have received local palliative radiotherapy of non-target lesions for local symptom control within the last 21 days must have recovered from any adverse effects of radiotherapy before recording screening symptoms. 8.No untreated brain metastasis or unstable neurologic condition after the completion of radiation, or requiring corticosteroid of > 40 mg prednisone daily equivalent dose to control the symptoms.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

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

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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