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No longer recruiting (closed or complete)Last updated: 6 July 2026

BG-68501-101: This study will assess whether a new form of targeted therapy is safe, effective and how well-tolerated it is in participants with advanced or metastatic solid tumoursA Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

BG-68501-101

Clinical summary

Summary

This study will test BG-68501, a new form of targted therapy, for treating advanced or metastatic solid tumours.

It will assess how safe the drug is, how well people can tolerate it, how the body processes it, and if it helps fight tumours.

The study will also find the best dose of BG-68501 for future research.

The study is made up of two parts. Part 1 (Dose Escalation) increases the dose of BG-68501 to find the right level, and Part 2 expands testing at that dose (Dose Expansion).

In Dose Escalation, cohorts of participants will receive increasing doses of BG-68501, both alone and with the drug fulvestrant, to see how well they work. 

In Dose Expansion the optimal dose of BG-68501 (both alone and with fulvestrant), found in Part 1, will be tested in specific groups of participants depending on their tumour type. 

In both Dose Escalation and Dose Expansion, BG-68501 will be administered orally and fulvestrant will be administered via intramuscular injection. 

Conditions

This trial is treating people with advanced solid tumours

Eligibility

Inclusion

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.

Exclusion

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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

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

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