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Examining the safety of BG-68501 for advanced-stage tumors

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

Phase 1 Interventional BeOne Medicines · NCT06257264

This study is testing a new drug called BG-68501 to see if it's safe and effective for people with advanced tumors that can't be removed by surgery.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment258 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionschemotherapy
Locations24 sites (Newport Beach, California and 23 other locations)
Trial IDNCT06257264 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates BG-68501, a cyclin-dependent kinase-2 inhibitor, to determine its safety, tolerability, and preliminary effectiveness in patients with advanced, nonresectable, or metastatic solid tumors. The study is divided into two parts: the first part focuses on dose escalation and safety expansion, while the second part involves dose expansion. Participants will receive BG-68501 either as a standalone treatment or in combination with fulvestrant and potentially BGB-43395. The goal is to identify the recommended dose for future studies.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors, particularly those with hormone receptor-positive breast cancer.

Not a fit: Patients with gastric cancer or gastroesophageal adenocarcinoma may not benefit from this study due to exclusion criteria.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced-stage tumors that are currently difficult to treat.

How similar studies have performed: Other studies involving CDK inhibitors have shown promise, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Part 1 (Dose Escalation) Inclusion Criteria:

* 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.

Part 1 (Safety Expansion) and Part 2 (Dose Expansion) Inclusion Criteria:

* 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.

General Inclusion Criteria:

* 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.

General Exclusion Criteria:

* 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.

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

Where this trial is running

Newport Beach, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerSmall Cell Lung CancerOvarian CancerGastric CancerHormone-receptor-positive Breast CancerHormone Receptor Positive HER-2 Negative Breast CancerAdvanced Solid TumorEndometrial Cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.