A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

April 23, 2024 updated by: BeiGene

A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors

This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors. The study will also identify a recommended dose for expansion (RDFE) in subsequent disease directed studies.

The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion) and Part 2 (dose expansion).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Cancer and Haematology Centre
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Genesiscare North Shore
  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Titan Health Partners Llc Dba Astera Cancer Care
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

General Inclusion Criteria:

  • Female participants with advanced or metastatic HR+/HER2- breast cancer will be required to have ovarian function suppression using gonadotropin hormone-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Adequate organ function.

Part 1 (Dose Escalation) Inclusion Criteria:

  • Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CDK2 dependency including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian, fallopian tube, primary peritoneal cancer (PROC), small cell lung cancer (SCLC), and others.
  • Participants should have received prior available systemic therapy for their condition and should be refractory to or intolerant of standard-of-care therapies.
  • Participants with advanced solid tumors must have measurable disease per RECIST 1.1.

Part 1 (Safety Expansion) Inclusion Criteria:

  • Participants with advanced or metastatic HR+/HER2- breast cancer, PROC, or SCLC.

Part 2 (Dose Expansion) Inclusion Criteria:

  • Participants with selected advanced or metastatic HR+/HER2- breast cancer, PROC, SCLC, or advanced solid tumors with a specific gene mutation based on standard-of-care testing.

General Exclusion Criteria:

  • Prior therapy selectively targeting CDK2 inhibition. 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. Participants with a history of treated central nervous system (CNS) metastases may be eligible if they meet additional criteria.
  • Any malignancy ≤ 3 years before the first dose of study treatment(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 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.
  • Any major surgical procedure ≤ 28 days before the first dose of study treatment(s).
  • Prior allogeneic stem cell transplantation, or organ transplantation.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation and Safety Expansion
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy and in combination with fulvestrant.
Drug: Fulvestrant
Standard dose administered via intramuscular injection.
Other Names:
  • Faslodex®
Drug: BG-68501
Planned doses administered orally.
Experimental: Part 2: Dose Expansion
The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant) from Part 1 will be evaluated in selected tumor cohorts.
Drug: Fulvestrant
Standard dose administered via intramuscular injection.
Other Names:
  • Faslodex®
Drug: BG-68501
Planned doses administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 24 months
Number of participants with treatment-emergent AEs and SAEs.
Up to approximately 24 months
Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501
Time Frame: Up to approximately 24 months
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Up to approximately 24 months
Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors
Time Frame: Up to approximately 24 months
RDFE of BG-68501 alone will be determined based upon the MTD or MAD.
Up to approximately 24 months
Part 1: RDFE of BG-68501 and fulvestrant in participants with hormone-receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer
Time Frame: Up to approximately 24 months
RDFE of BG-68501 in combination with fulvestrant will be determined based upon the MTD or MAD.
Up to approximately 24 months
Part 2: Objective Response Rate
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). CR and PR that is confirmed by repeat assessments, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: ORR
Time Frame: Up to approximately 24 months
ORR is defined as the percentage of participants with best overall response of CR or PR. CR and PR that is confirmed by repeat assessments, as assessed by the investigator using RECIST v1.1.
Up to approximately 24 months
Part 2: Number of participants with AEs and SAEs
Time Frame: Up to approximately 24 months
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
Up to approximately 24 months
Parts 1 and 2: Duration of Response (DOR)
Time Frame: Up to approximately 24 months
DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.
Up to approximately 24 months
Parts 1 and 2: Time to Response (TTR)
Time Frame: Up to approximately 24 months
TTR is defined as the time from the treatment initiation to the first determination of overall response by the investigator using RECIST v1.1.
Up to approximately 24 months
Parts 1 and 2: Disease Control Rate (DCR)
Time Frame: Up to approximately 24 months
DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed by the investigator using RECIST v1.1.
Up to approximately 24 months
Parts 1 and 2: Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 24 months
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.
Up to approximately 24 months
Part 1: Maximum observed plasma concentration (Cmax) for BG-68501
Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Part 1: Observed plasma trough concentration (Ctrough) for BG-68501
Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Part 1: Area under the concentration-time curve (AUC) for BG-68501
Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Part 1: Half-life (t1/2) for BG-68501
Time Frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Part 2: Plasma concentrations for BG-68501
Time Frame: From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)
From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Investigators

  • Study Director: Study Director, BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BG-68501-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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