BGM-2121 for adults with advanced solid tumors
A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
This tests whether BGM-2121 is safe and may help adults whose advanced solid tumors have not responded to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioGate Precision Medicine Corp. Industry-sponsored |
| Locations | 3 sites (Tainan and 2 other locations) |
| Trial ID | NCT07346846 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, early-phase interventional trial to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of BGM-2121 in adults with advanced solid tumors. Eligible participants are adults with confirmed advanced solid tumors, measurable disease by RECIST, and prior progression after standard-of-care therapies. The trial enrolls at clinical sites in Taiwan and will monitor adverse events, drug levels, and tumor responses to identify safe dose(s) and any signs of efficacy. Results will guide further development and dosing decisions for subsequent studies.
Who should consider this trial
Good fit: Adults aged 18 or older with confirmed advanced solid tumors, measurable lesions, and prior failure of standard anti-cancer therapy are the intended candidates for this study.
Not a fit: Patients with unresolved toxicity from prior treatments, signs of end-stage organ failure or major uncontrolled chronic illnesses, or a recent other primary malignancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, BGM-2121 could provide a new treatment option that stabilizes or shrinks tumors for some patients who have exhausted standard therapies.
How similar studies have performed: Some early-phase trials of novel oncology agents in similar populations have shown occasional promising responses, but BGM-2121 itself appears novel and unproven in published reports.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. With either gender aged ≥ 18 years, 2. Has a confirmed diagnosis of advanced solid tumor(s), 3. The subject has received and failed standard-of-care anti-cancer therapy 4. Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 5. ... Exclusion Criteria: 1. Has any ongoing toxicity from previous anti-cancer treatments 2. Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s) 3. History of another primary malignancy within the last three years 4. ...
Where this trial is running
Tainan and 2 other locations
- National Cheng Kung University Hospital — Tainan, Taiwan (Not_yet_recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Not_yet_recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Queena Hwang
- Email: clinical@biogate.com.tw
- Phone: 886-2-2517-6512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.