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RecruitingLast updated: 23 February 2024

This study is exploring the recommended dosing for a new targeted therapy when given alone, or in combination with hormone therapy, in people with HR+/HER2- breast cancer and other advanced cancersA Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Clinical summary

Summary

This study has two phases: Dose Escalation and Dose Expansion.

In the Dose Escalation phase (Phase 1a), sequential cohorts of increasing dose levels of the investigational targeted therapy (called BGB-43395) will be evaluated as monotherapy or in combination with hormone therapy (either fulvestrant or letrozole). 

In the Dose Expansion phase (Phase 1b) the recommended dose for expansion (RDFE) for BGB-43395 (in combination with fulvestrant) from Phase 1a will be evaluated in HR+ breast cancer and selected tumour cohorts. 

Conditions

This trial is treating patients with advanced, metastatic or inoperable solid cancers associated with dependency on CDK4, including HR+ breast cancer, non-small cell lung cancer and anothers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

BeiGene

Scientific Title

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Eligibility

Inclusion

  • Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, non-small cell lung cancer, and others.
  • Phase 1a: Received prior therapy for their condition (if available) and should be refractory to or intolerant of standard-of-care therapies.
  • Phase 1b (Dose Expansion): Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types.
  • Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
  • Adequate organ function.

Exclusion

  • Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available).
  • Known leptomeningeal disease or uncontrolled, untreated brain metastasis.
  • Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  • Uncontrolled diabetes.
  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
  • History of hepatitis B or active hepatitis C infection.
  • Prior allogeneic stem cell transplantation, or organ transplantation.

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • 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.

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