BGM-2121 for adults with advanced solid tumors
Official title: A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors
Run by BioGate Precision Medicine Corp. · NCT07346846 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | BioGate Precision Medicine Corp. Industry-sponsored |
| Locations | 3 sites (Tainan and 2 other locations) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | November 2027 |
| Study ends | December 2028 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07346846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Taipei Veterans General Hospital
Taipei, Taiwan Recruiting -
National Cheng Kung University Hospital
Tainan, Taiwan Not yet recruiting -
National Taiwan University Hospital
Taipei, Taiwan Not yet recruiting
Study contacts
- Study coordinator: Queena Hwang
- Email: clinical@biogate.com.tw
- Phone: 886-2-2517-6512
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.