A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-… (NCT06257264) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
United States, Australia, China103 participantsStarted 2024-03-11
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since BG-68501 is being studied in Phase 1, which means researchers are still figuring out the right dose and basic safety profile, what is currently known about the side effects people have experienced so far, and how would that risk level compare to my other treatment options?
2This trial is listed as 'active not recruiting,' which means they are no longer enrolling new patients — does that mean this specific trial is off the table for me, or are there related studies with BG-68501 that I might still be eligible for?
3My cancer type is one of the conditions listed — like hormone-receptor-positive breast cancer or triple-negative breast cancer — so could you help me understand whether the part of this trial that might have been most relevant to me, such as the combination with fulvestrant and BGB-43395 for HR+/HER2- breast cancer, would have been a realistic fit given where my disease stands right now?
4Because Phase 1 trials are primarily designed to test safety and find the right dose rather than to prove the treatment works, would it make sense for me to try an established standard treatment first, or is there a reason a trial like this might be worth prioritizing at this stage of my diagnosis?
5The trial is measuring something called Objective Response Rate in its second part — can you explain what that means in plain terms, and whether any early signals from this study or similar drugs in its class might give us a sense of whether this approach could be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 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
Timeframe: Up to approximately 24 months
3
Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 monotherapy in participants with solid tumors
Timeframe: 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