A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
3 other identifiers
interventional
258
6 countries
24
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Mar 2024
Typical duration for phase_1 breast-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedStudy Start
First participant enrolled
March 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 22, 2026
April 1, 2026
4.1 years
February 5, 2024
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent AEs and SAEs.
From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months
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.
Up to approximately 24 months
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.
Up to approximately 24 months
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.
Up to approximately 24 months
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.
Up to approximately 20 months
Secondary Outcomes (11)
Part 1: ORR
Up to approximately 20 months
Part 2: Number of participants with AEs and SAEs
From the first dose of study drug(s) to 30 days after the last dose; approximately 6-12 months
Parts 1 and 2: Duration of Response (DOR)
Up to approximately 20 months
Parts 1 and 2: Time to Response (TTR)
Up to approximately 20 months
Parts 1 and 2: Disease Control Rate (DCR)
Up to approximately 20 months
- +6 more secondary outcomes
Study Arms (5)
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.
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.
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.
Part 1: Food Effect Evaluation
EXPERIMENTALParticipants 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.
Part 2: Dose Expansion
EXPERIMENTALThe RFDE for BG-68501 (as monotherapy and in combination with fulvestrant and BGB-43395) from Part 1 will be evaluated in selected tumor cohorts.
Interventions
Planned doses administered orally.
Standard dose administered via intramuscular injection.
Planned doses administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (24)
Hoag Memorial Presbyterian
Newport Beach, California, 92663-4162, United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, 32746-2115, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, 08816-4096, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105-2108, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, NSW 2010, Australia
Nepean Hospital
Kingswood, New South Wales, NSW 2747, Australia
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
Cancer Research South Australia
Adelaide, South Australia, SA 5000, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Shengjing Hospital of China Medical Universityhuaxiang Branch
Shenyang, Liaoning, 110022, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Rambam Health Care Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025, Moldova
Auckland City Hospital
Auckland, 1023, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 13, 2024
Study Start
March 11, 2024
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.