Actively Recruiting
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Led by BeiGene · Updated on 2026-05-11
258
Participants Needed
24
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with advanced or metastatic solid tumors associated with CDK2 dependency, including hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer, platinum refractory or resistant serous ovarian cancer, endometrial cancer, and others
- Prior standard systemic therapies for advanced or metastatic disease required
- Participants with hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer must have received endocrine therapy and a CDK4/6 inhibitor if enrolled in combination cohorts
- Participants with platinum refractory or resistant serous ovarian cancer must have received at least one line of platinum-containing chemotherapy for advanced disease and no more than four prior therapeutic regimens
- Female participants with hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer must have ovarian function suppression or be postmenopausal
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Adequate organ function
- Participants in dose escalation must have measurable disease; bone-only disease allowed for hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer
- In safety expansion and dose expansion, participants must have at least one measurable lesion per RECIST version 1.1
You will not qualify if you...
- Prior therapy selectively targeting CDK2 inhibition
- For triple combination cohorts, prior therapy targeting CDK2 or selectively targeting CDK4 (prior CDK4/6 inhibitor therapy allowed where approved)
- Known leptomeningeal disease or untreated, uncontrolled brain metastases
- Any malignancy within three years before first dose except the specific cancer under investigation or certain treated local cancers
- Uncontrolled diabetes
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 28 days before first dose, or symptomatic COVID-19 infection
- Active hepatitis B or C infection
- Major surgical procedure within 28 days before first dose
- Prior allogeneic stem cell transplantation or organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Hoag Memorial Presbyterian
Newport Beach, California, United States, 92663-4162
Actively Recruiting
2
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, United States, 32746-2115
Completed
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
4
Titan Health Partners Llc Dba Astera Cancer Care
East Brunswick, New Jersey, United States, 08816-4096
Actively Recruiting
5
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-2108
Actively Recruiting
6
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
7
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
8
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, NSW 2010
Actively Recruiting
9
Nepean Hospital
Kingswood, New South Wales, Australia, NSW 2747
Actively Recruiting
10
Genesiscare North Shore
St Leonards, New South Wales, Australia, NSW 2065
Actively Recruiting
11
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, QLD 4102
Actively Recruiting
12
Cancer Research South Australia
Adelaide, South Australia, Australia, SA 5000
Actively Recruiting
13
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
14
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
15
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
16
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, China, 510245
Actively Recruiting
17
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
19
Shengjing Hospital of China Medical Universityhuaxiang Branch
Shenyang, Liaoning, China, 110022
Actively Recruiting
20
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
21
Rambam Health Care Center
Haifa, Israel, 3109601
Actively Recruiting
22
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
23
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova, 2025
Actively Recruiting
24
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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