NCT07226349 A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
| NCT ID | NCT07226349 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | BeOne Medicines |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 105 participants in total. It began in 2025-12-11 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * Participants must have measurable disease as assessed by RECIST v1.1. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have adequate organ function. * Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced/metastatic disease, or for whom standard therapy is not available or not tolerated. * Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting. * Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4/6 inhibitor-progressed solid tumors. * Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced/metastatic setting. Exclusion Criteria: * For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation. * For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4/6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available. * Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact & Investigator
Study Director
STUDY DIRECTOR
BeOne Medicines
Frequently Asked Questions
Who can join the NCT07226349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226349 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07226349 currently recruiting?
Yes, NCT07226349 is actively recruiting participants. Contact the research team at clinicaltrials@beonemed.com for enrollment information.
Where is the NCT07226349 trial being conducted?
This trial is being conducted at Birmingham, United States, New Haven, United States, Baltimore, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT07226349 clinical trial?
NCT07226349 is sponsored by BeOne Medicines. The principal investigator is Study Director at BeOne Medicines. The trial plans to enroll 105 participants.