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Breast CancerPhase 1NCT06257264

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

A Phase 1 study testing BG-68501, Fulvestrant and BGB-43395 in people with Breast Cancer and Small Cell Lung Cancer, run by BeiGene at 24 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 as… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BG-68501, Fulvestrant and BGB-43395
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
24 sitesin 6 countries
Study dates
11 Mar 2024to 27 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

24 sites in 6 countries.

24 sites in 6 countries

Australia7 sites

  • Cancer Research South Australia

    Adelaide, South Australia, SA 5000

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, NSW 2010

  • Nepean Hospital

    Kingswood, New South Wales, NSW 2747

  • Genesiscare North Shore

    St Leonards, New South Wales, NSW 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, QLD 4102

Other trials in Australia

China7 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    Guangzhou, Guangdong, 510245

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Shengjing Hospital of China Medical Universityhuaxiang Branch

    Shenyang, Liaoning, 110022

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

United States6 sites

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Titan Health Partners Llc Dba Astera Cancer Care

    East Brunswick, New Jersey, 08816-4096

  • Florida Cancer Specialists and Research Institute

    Lake Mary, Florida, 32746-2115

  • Hoag Memorial Presbyterian

    Newport Beach, California, 92663-4162

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-2108

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

Other trials in United States

Israel2 sites

  • Rambam Health Care Center

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

Other trials in Israel

Moldova1 site

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025

Other trials in Moldova

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: 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 as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies.

The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).

Being tested
BG-68501, Fulvestrant, BGB-43395
Keywords
breast cancer, small cell lung cancer, ovarian cancer, gastric cancer, cdk2 inhibitor, BG-68501, HR+ HER2- breast cancer, endometrial cancer, prostate cancer, BGB-43395, bladder cancer, urothelial cancer, gastroesophageal cancer, cdk4 inhibitor, fulvestrant
Medical subject headings
Breast Neoplasms, Small Cell Lung Carcinoma, Ovarian Neoplasms, Stomach Neoplasms, Endometrial Neoplasms, Prostatic Neoplasms, Triple Negative Breast Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG-68501Drug

    Planned doses administered orally.

  • FulvestrantDrug

    Standard dose administered via intramuscular injection.

  • BGB-43395Drug

    Planned doses administered orally.

Study groups in NCT06257264
Study groupRoleWhat they receive
Part 1 Part A: Dose Escalation and Safety Expansion (BG-68501 Monotherapy)ExperimentalSequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy.
Receives: Drug: BG-68501
Part 1 Part B: Dose Escalation (BG-68501 + Fulvestrant)ExperimentalSequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant.
Receives: Drug: BG-68501; Drug: Fulvestrant
Part 1 Part C: Dose Escalation and Safety Expansion (BG-68501 + Fulvestrant + BGB-43395)ExperimentalSequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant and BGB-43395.
Receives: Drug: BG-68501; Drug: Fulvestrant; Drug: BGB-43395
Part 1: Food Effect EvaluationExperimentalParticipants will receive BG-68501 at a dose level that is determined safe and tolerable to evaluate food effect. Food effect may also be evaluated for BG-68501 in combination with fulvestrant.
Receives: Drug: BG-68501; Drug: Fulvestrant
Part 2: Dose ExpansionExperimentalThe RFDE for BG-68501 (as monotherapy and in combination with fulvestrant and BGB-43395) from Part 1 will be evaluated in selected tumor cohorts.
Receives: Drug: BG-68501; Drug: Fulvestrant; Drug: BGB-43395

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants with treatment-emergent AEs and SAEs.

    Measured: From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months

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

    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.

    Measured: Up to approximately 24 months

  3. Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 monotherapy in participants with solid tumors

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

    Measured: Up to approximately 24 months

  4. Part 1: RDFE of BG-68501 in combination with fulvestrant and BGB-43395 in participants with HR+/HER2- BC

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

    Measured: Up to approximately 24 months

  5. Part 2: Objective Response Rate (ORR)

    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.

    Measured: Up to approximately 20 months

Secondary outcomes (11)

  1. Part 1: ORR

    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.

    Measured: Up to approximately 20 months

  2. Part 2: Number of participants with AEs and SAEs

    Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.

    Measured: From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months

  3. Parts 1 and 2: Duration of Response (DOR)

    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.

    Measured: Up to approximately 20 months

  4. Parts 1 and 2: Time to Response (TTR)

    TTR is defined as the time from the treatment initiation to the first determination of overall response by the investigator using RECIST v1.1.

    Measured: Up to approximately 20 months

  5. Parts 1 and 2: Disease Control Rate (DCR)

    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.

    Measured: Up to approximately 20 months

  6. Parts 1 and 2: Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks assessed by the investigator using RECIST v1.1.

    Measured: Up to approximately 20 months

  7. Part 1: Maximum observed plasma concentration (Cmax) for BG-68501 and BGB-43395

    Measured: 2 times in the first 2 months

  8. Part 1: Observed plasma trough concentration (Ctrough) for BG-68501 and BGB-43395

    Measured: 5 times in the first 2 months

  9. Part 1: Area under the concentration-time curve (AUC) for BG-68501 and BGB-43395

    Measured: 2 times in the first 2 months

  10. Part 1: Half-life (t1/2) for BG-68501 and BGB-43395

    Measured: 2 times in the first 2 months

  11. Part 2: Plasma concentrations for BG-68501 and BGB-43395

    Measured: 5 times in approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start11 Mar 2024
  3. Primary completion27 Aug 2026
  4. Study completion27 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257264
Sponsor's protocol ID
BG-68501-101
Other IDs
CTR20243059, 2024-517324-19-00
Status last verified
Oct 2026
First submitted
5 Feb 2024
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG-68501, Fulvestrant and BGB-43395 in people with Breast Cancer and Small Cell Lung Cancer, run by BeiGene at 24 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Australia, China, United States, Israel, Moldova and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06257264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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