Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment35 (estimated)
SponsorBioGate Precision Medicine Corp.
Industry-sponsored
Locations3 sites (Tainan and 2 other locations)
StatusRecruiting
StartedMarch 10, 2026
Main results expectedNovember 2027
Study endsDecember 2028
Registry record updatedApril 21, 2026
Trial IDNCT07346846 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • CG-7321: a first-in-human test in advanced solid tumors

    We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

    Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

  • AK157D1 injection for advanced solid tumors

    A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

    Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

  • ABBV-253 in adults with advanced solid tumors

    This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

    Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

  • MK-2010 alone or with other treatments for advanced solid tumors

    This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.

    Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

  • Whole-Body Infrared Heating for Advanced Solid Tumors

    This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.

    Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

  • MK-2010 with Sac-TMT in advanced solid tumors

    This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

    Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.