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BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT06120283
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This is a dose escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer Hormone-receptor-positive Breast Cancer Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Malignant Neoplasm of Breast HER2-negative Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer Non-small Cell Lung Cancer Drug: BGB-43395 Drug: Fulvestrant Drug: Letrozole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 1, 2023
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole.
 Drug: BGB-43395
Planned doses administered orally.

Drug: Fulvestrant
Standard dose administered via intramuscular injection.
Other Name: Faslodex®

Drug: Letrozole
Standard dose administered orally as a tablet.
Other Name: Femara®
Experimental: Dose Expansion
Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant) from Phase 1a will be evaluated in HR+ breast cancer and selected tumor cohorts.
 Drug: BGB-43395
Planned doses administered orally.

Drug: Fulvestrant
Standard dose administered via intramuscular injection.
Other Name: Faslodex®


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 3 years ]
    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

  2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395 [ Time Frame: Up to approximately 3 years ]
    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached.

  3. Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395 [ Time Frame: Up to approximately 3 years ]
    RDFE of BGB-43395 alone or in combination with fulvestrant or letrozole will be determined based upon the MTD or MAD.

  4. Phase 1b: Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.


Secondary Outcome Measures :
  1. Phase 1a: ORR [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the percentage of participants who have confirmed CR or PR assessed by the investigator using RECIST v1.1.

  2. Phase 1a and 1b: Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR is defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

  3. Phase 1a and 1b: Time to Response (TTR) [ Time Frame: Up to approximately 3 years ]
    TTR is defined as the time from the date of the first dose of study drugs to the date of the first determination of objective response by the investigator using RECIST v1.1.

  4. Phase 1b: Disease Control Rate (DCR) [ Time Frame: Up to approximately 3 years ]
    DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease assessed by the investigator using RECIST v1.1.

  5. Phase 1b: Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 3 years ]
    CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.

  6. Phase 1b: Progression-Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.

  7. Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 3 years ]
    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.

  8. Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395 and its metabolite [ Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) ]
  9. Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395 and its metabolite [ Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) ]
  10. Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite [ Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) ]
  11. Phase 1a: Half-life (t1/2) of BGB-43395 and its metabolite [ Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days) ]
  12. Phase 1b: Plasma concentrations of BGB-43395 and its metabolite [ Time Frame: From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment.
  • 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 without symptomatic visceral disease.

Exclusion Criteria:

  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06120283


Contacts
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Contact: Study Director 1.877.828.5568 clinicaltrials@beigene.com

Locations
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United States, Colorado
Sarah Cannon Research Institute (Scri) At Health One Recruiting
Denver, Colorado, United States, 80219
United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
James Cancer Hospital and Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
The University of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Blacktown Cancer and Haematology Centre Recruiting
Blacktown, New South Wales, Australia, 2148
Macquarie University Recruiting
North Ryde, New South Wales, Australia, 2109
Australia, Victoria
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Peter Maccallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT06120283    
Other Study ID Numbers: BGB-43395-101
2023-506888-34-00 ( Registry Identifier: EU CTIS )
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: April 24, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BeiGene:
breast cancer
advanced solid tumor
advanced breast cancer
hormone receptor positive breast cancer
 HER2-negative breast cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
BGB-43395
non-small cell lung cancer
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Letrozole
Fulvestrant
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists