Your session is about to expire
← Back to Search
CDK2 Inhibitor
BG-68501 + Fulvestrant for Breast Cancer
Phase 1
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with advanced or metastatic HR+/HER2- breast cancer, PROC, or SCLC
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Must not have
History of hepatitis B or active hepatitis C infection
Uncontrolled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called BG-68501 in patients with advanced solid tumors to see if it is safe, how the body processes it, its effects on the tumor, and its initial
Who is the study for?
This trial is for adults with advanced-stage tumors, including breast, ovarian, endometrial, prostate, stomach cancers and SCLC. They must have tried standard treatments without success or be unable to tolerate them. Women with certain types of breast cancer need hormone suppression or be postmenopausal. Participants should be relatively healthy otherwise (ECOG ≤ 1) and have measurable disease.
What is being tested?
The study tests BG-68501, a new drug aimed at stopping tumor growth by inhibiting CDK2—a protein that helps cancer cells multiply. It's given in two parts: first to find the safest dose (dose escalation), then to see how well it works at this dose (dose expansion). The trial also includes Fulvestrant for comparison.
What are the potential side effects?
Possible side effects are not detailed but may include typical reactions related to drugs targeting cell division such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems; specific side effects will become clearer as the trial progresses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and it is either HR+/HER2-, ovarian, or small cell lung cancer.
Select...
I am fully active or can carry out light work.
Select...
My cancer is advanced or has spread and may respond to treatments targeting CDK2.
Select...
I am a woman with advanced breast cancer and am either postmenopausal or receiving hormone therapy to suppress ovarian function.
Select...
I've tried all standard treatments for my condition without success or couldn't tolerate them.
Select...
My cancer is advanced, has specific gene mutations, and is not HER2 positive.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had hepatitis B or currently have hepatitis C.
Select...
My diabetes is not well-managed.
Select...
I haven't had major surgery in the last 4 weeks.
Select...
I have had a stem cell or organ transplant in the past.
Select...
I haven't taken antibiotics, antifungals, or antivirals in the last 28 days and don't have COVID-19 symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part 1: RDFE of BG-68501 in combination with fulvestrant and BGB-43395 in participants with HR+/HER2- BC
+2 moreSecondary study objectives
Part 1: ORR
Part 2: Number of participants with AEs and SAEs
Parts 1 and 2: Clinical Benefit Rate (CBR)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment3 Interventions
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.
Group II: Part 1 Part C: Dose Escalation and Safety Expansion (BG-68501 + Fulvestrant + BGB-43395)Experimental Treatment3 Interventions
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant and BGB-43395.
Group III: Part 1 Part B: Dose Escalation (BG-68501 + Fulvestrant)Experimental Treatment2 Interventions
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated in combination with fulvestrant.
Group IV: Part 1 Part A: Dose Escalation and Safety Expansion (BG-68501 Monotherapy)Experimental Treatment1 Intervention
Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3790
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
200 Previous Clinical Trials
31,352 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,288 Previous Clinical Trials
501,614 Total Patients Enrolled