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Study of BG-68501 for Advanced Solid Tumors

This study is testing BG-68501, a new oral medication, to see how safe it is and what doses work best for people with advanced solid tumors, including breast, small cell lung, ovarian, and gastric cancers. It's also looking at how well BG-68501 works alone or with other drugs like fulvestrant and BGB-43395, especially for a type of breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-). The study aims to find the safest and most effective dose of BG-68501. You may be able to join if you are 18 or older and have certain advanced solid tumors, including those potentially associated with CDK2 dependency. The study is currently unclear on its recruitment status and plans to enroll about 103 participants.

Study design
This is a first-in-human (FIH) Phase 1a/1b study, meaning it's one of the first times this drug is being tested in people. It will involve about 103 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects from the first dose until 30 days after their last dose, which is expected to be approximately 6-12 months. The study will also track the maximum tolerated dose and recommended dose for expansion for up to approximately 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06257264

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
BeiGene
~103 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:BG-68501FulvestrantBGB-43395

At a glance

Recruiting sites
0 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months
+4 more outcomes measured

Conditions

Breast Cancer
Small Cell Lung Cancer
Ovarian Cancer
Gastric Cancer
Hormone-receptor-positive Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
Advanced Solid Tumor
Endometrial Cancer
Prostate Cancer
TNBC - Triple-Negative Breast Cancer
GastroEsophageal Cancer
Bladder Cancer

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Where it's being run

24 sites across 19 states
New South Wales4
Beijing Municipality2
Israel2
California1
Florida1
Missouri1
New Jersey1
South Dakota1

Study leadership

  • Study Director · STUDY_DIRECTOR · BeiGene

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Monotherapy Cohorts: 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 cancer (PROC), endometrial cancer, and others. Prior available standard-of-care systemic therapies for advanced or metastatic disease are required. The requirements for enrollment into a food effect evaluation cohort are the same as the monotherapy cohorts with the exception that participants with gastric cancer and gastroesophageal adenocarcinoma are excluded.
Combination Cohorts (BG-68501 with fulvestrant with or without BGB-43395): Enrollment is restricted to only participants with HR+/HER2- BC. In regions where approved and available, participants must have received one or more lines of treatment for advanced/metastatic disease as well as prior endocrine therapy and a CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. If applicable, the requirements for enrollment into a food effect evaluation cohort are the same as the combination cohorts.
Participants with advanced, non-resectable, or metastatic HR+/HER2- BC or PROC, including fallopian tube or primary peritoneal cancer.
PROC participants must have received:
≥ 1 line of platinum-containing chemotherapy for advanced disease.
≤ 4 prior therapeutic regimens in the advanced/metastatic setting.
HR+/HER2- BC:
Participants enrolled in regions where CDK4/6 inhibitors are approved and available must have received ≥ 1 line of therapy including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy or ADC treatments for advanced disease.
Female participants with advanced or metastatic HR+/HER2- BC 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.
For dose escalation, participants with advanced solid tumors other than HR+/HER2- BC must have measurable disease per RECIST 1.1. Participants with HR+/HER2- BC with bone-only disease are eligible for dose escalation only. For safety expansion and dose expansion, all participants must have ≥1 measurable lesion per RECIST v 1.1.

Exclusion

For all cohorts: Prior therapy selectively targeting CDK2 inhibition.
For triple combination cohorts: Prior therapy targeting CDK2 or 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. 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, treated papillary thyroid carcinoma, 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.
Active hepatitis B infection 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.

What this trial measures

  • Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months

    Number of participants with treatment-emergent AEs and SAEs.

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

  • Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 monotherapy in participants with solid tumorsUp to approximately 24 months

    RDFE of BG-68501 alone will be determined based upon the MTD or MAD.

  • Part 1: RDFE of BG-68501 in combination with fulvestrant and BGB-43395 in participants with HR+/HER2- BCUp to approximately 24 months

    RDFE of BG-68501 in combination with fulvestrant and BGB-43395 will be determined based upon the MTD or MAD.

  • Part 2: Objective Response Rate (ORR)Up to approximately 20 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.