NCT07346846

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
28mo left

Started Mar 2026

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Dec 2028

First Submitted

Initial submission to the registry

November 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

November 25, 2025

Last Update Submit

April 16, 2026

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Determination of Maximum Tolerated Dose (MTD) to establish RP2D

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

  • Incidence of Anti-Drug Antibodies (ADAs)

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

  • Peak Serum Concentration (Cmax) of BGM-2121

    From first dose through 30 days after the last dose

  • Area under Curve (AUC) of BGM-2121

    From first dose through 30 days after the last dose

  • Objective Response Rate (ORR)

    From baseline through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

BGM-2121

EXPERIMENTAL
Drug: BGM-2121

Interventions

BGM-2121DRUG

BGM-2121 treatment

BGM-2121

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Central Study Contacts

Queena Hwang

CONTACT

886-2-2517-6512clinical@biogate.com.tw

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 16, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)