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NCT Number: NCT07346846

A Study of BGM-2121 in Patients With Advanced Solid Tumors

This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cheng Kung University Hospital, Tainan, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • With either gender aged ≥ 18 years,
  • Has a confirmed diagnosis of advanced solid tumor(s),
  • The subject has received and failed standard-of-care anti-cancer therapy
  • Has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • ...

Exclusion criteria

  • Has any ongoing toxicity from previous anti-cancer treatments
  • Has signs or symptoms of end-stage organ failure, major chronic illnesses other than cancer(s)
  • History of another primary malignancy within the last three years
  • ...

Treatment and study plan

BGM-2121

Drug

BGM-2121 treatment

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: From first dose through the DLT evaluation period (28 days)

    Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria.

  2. Treatment Discontinuation Due to Drug-Related Adverse Events

    Time frame: From first dose through study completion, an average of 1 year

    Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0.

  3. Incidence of Treatment-Emergent and Treatment-Related Adverse Events

    Time frame: From first dose through 6 weeks after the last dose of study treatment

    Incidence, type, and timing of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), graded per CTCAE v5.0.

  4. Number of Participants With Grade ≥3 Laboratory Abnormalities

    Time frame: From first dose through study completion, an average of 1 year

    Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria

  5. Changes in Electrocardiogram (ECG) Parameters

    Time frame: From baseline through study completion, an average of 1 year

    Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration.

Secondary outcomes

  1. Determination of Maximum Tolerated Dose (MTD) to establish RP2D

    Time frame: From first dose through the DLT evaluation period (28 days)

    MTD of BGM-2121 in subjects with advanced solid tumors, used to determine the recommended Phase 2 dose (RP2D).

  2. Incidence of Anti-Drug Antibodies (ADAs)

    Time frame: From first dose through 6 weeks after the last dose of study treatment

    Percentage of subjects who develop treatment-emergent ADAs during the study.

  3. Peak Serum Concentration (Cmax) of BGM-2121

    Time frame: From first dose through 30 days after the last dose

    Cmax derived from serum concentration data.

  4. Area under Curve (AUC) of BGM-2121

    Time frame: From first dose through 30 days after the last dose

    AUC derived from serum concentration data.

  5. Objective Response Rate (ORR)

    Time frame: From baseline through study completion, an average of 1 year

    Percentage of subjects with complete or partial response according to RECIST 1.1 criteria.

  6. Progression-Free Survival (PFS)

    Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 weeks

    Time from first treatment to documented disease progression or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Queena Hwang

CONTACT

[email protected]

886-2-2517-6512 ext. 8556

Sponsors and collaborators

Lead sponsor

BioGate Precision Medicine Corp.

Industry

Registry information

Official study title

A Phase 1 First-in-human Study of BGM-2121 in Patients With Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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