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CDK2 Inhibitor

BG-68501 + Fulvestrant for Breast Cancer

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Must not have

History of hepatitis B or active hepatitis C infection

Uncontrolled diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BG-68501 in patients with advanced solid tumors to see if it is safe, how the body processes it, its effects on the tumor, and its initial

Who is the study for?

This trial is for adults with advanced-stage tumors, including breast, ovarian, endometrial, prostate, stomach cancers and SCLC. They must have tried standard treatments without success or be unable to tolerate them. Women with certain types of breast cancer need hormone suppression or be postmenopausal. Participants should be relatively healthy otherwise (ECOG ≤ 1) and have measurable disease.

What is being tested?

The study tests BG-68501, a new drug aimed at stopping tumor growth by inhibiting CDK2—a protein that helps cancer cells multiply. It's given in two parts: first to find the safest dose (dose escalation), then to see how well it works at this dose (dose expansion). The trial also includes Fulvestrant for comparison.

What are the potential side effects?

Possible side effects are not detailed but may include typical reactions related to drugs targeting cell division such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems; specific side effects will become clearer as the trial progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread, and it is either HR+/HER2-, ovarian, or small cell lung cancer.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread and may respond to treatments targeting CDK2.

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I am a woman with advanced breast cancer and am either postmenopausal or receiving hormone therapy to suppress ovarian function.

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I've tried all standard treatments for my condition without success or couldn't tolerate them.

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My cancer is advanced, has specific gene mutations, and is not HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had hepatitis B or currently have hepatitis C.

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My diabetes is not well-managed.

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I haven't had major surgery in the last 4 weeks.

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I have had a stem cell or organ transplant in the past.

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I haven't taken antibiotics, antifungals, or antivirals in the last 28 days and don't have COVID-19 symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501

Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

+2 more

Secondary study objectives

Part 1: ORR

Part 2: Number of participants with AEs and SAEs

Parts 1 and 2: Clinical Benefit Rate (CBR)

+3 more