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

A Phase 1 First-in-human 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BGM-2121

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Queena Hwang; Phone Number: 8556 886-2-2517-6512; Email: clinical@biogate.com.tw

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Not yet recruiting
    • National Cheng Kung University Hospital
    • Contact: Queena Hwang; Phone Number: 886-2-2517-6512; Email: clinical@biogate.com.tw
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Queena Hwang; Phone Number: 8556 886-2-2517-6512; Email: clinical@biogate.com.tw
  • Taipei, Taiwan
    • Not yet recruiting
    • National Taiwan University Hospital
    • Contact: Queena Hwang; Phone Number: 886-2-2517-6512; Email: clinical@biogate.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. ...

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGM-2121	Drug: BGM-2121; BGM-2121 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-Limiting Toxicities (DLTs)	Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria.	From first dose through the DLT evaluation period (28 days)
Treatment Discontinuation Due to Drug-Related Adverse Events	Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0.	From first dose through study completion, an average of 1 year
Incidence of Treatment-Emergent and Treatment-Related Adverse Events	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.	From first dose through 6 weeks after the last dose of study treatment
Number of Participants With Grade ≥3 Laboratory Abnormalities	Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria	From first dose through study completion, an average of 1 year
Changes in Electrocardiogram (ECG) Parameters	Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration.	From baseline through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Maximum Tolerated Dose (MTD) to establish RP2D	MTD of BGM-2121 in subjects with advanced solid tumors, used to determine the recommended Phase 2 dose (RP2D).	From first dose through the DLT evaluation period (28 days)
Incidence of Anti-Drug Antibodies (ADAs)	Percentage of subjects who develop treatment-emergent ADAs during the study.	From first dose through 6 weeks after the last dose of study treatment
Peak Serum Concentration (Cmax) of BGM-2121	Cmax derived from serum concentration data.	From first dose through 30 days after the last dose
Area under Curve (AUC) of BGM-2121	AUC derived from serum concentration data.	From first dose through 30 days after the last dose
Objective Response Rate (ORR)	Percentage of subjects with complete or partial response according to RECIST 1.1 criteria.	From baseline through study completion, an average of 1 year
Progression-Free Survival (PFS)	Time from first treatment to documented disease progression or death.	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

Collaborators and Investigators

• Sponsor: BioGate Precision Medicine Corp.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BGM-2121-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No