A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
NCT ID: NCT06257264
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
258 participants
INTERVENTIONAL
2024-03-11
2028-07-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Part A: Dose Escalation and Safety Expansion (BG-68501 Monotherapy)
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy.
BG-68501
Planned doses administered orally.
Part 1 Part B: Dose Escalation (BG-68501 + Fulvestrant)
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant.
BG-68501
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
Part 1 Part C: Dose Escalation and Safety Expansion (BG-68501 + Fulvestrant + BGB-43395)
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant and BGB-43395.
BG-68501
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
BGB-43395
Planned doses administered orally.
Part 1: Food Effect Evaluation
Participants 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.
BG-68501
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
Part 2: Dose Expansion
The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant and BGB-43395) from Part 1 will be evaluated in selected tumor cohorts.
BG-68501
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
BGB-43395
Planned doses administered orally.
Interventions
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BG-68501
Planned doses administered orally.
Fulvestrant
Standard dose administered via intramuscular injection.
BGB-43395
Planned doses administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Hoag Memorial Presbyterian
Newport Beach, California, United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States
Washington University School of Medicine
St Louis, Missouri, United States
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shengjing Hospital Affiliated of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Rambam Health Care Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, , Moldova
Auckland City Hospital
Auckland, , New Zealand
Countries
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Central Contacts
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Other Identifiers
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CTR20243059
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-517324-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
BG-68501-101
Identifier Type: -
Identifier Source: org_study_id