Recruiting
Phase 1

BG-T187

Sponsor:

BeOne Medicines

Code:

NCT06598800

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Drug: BG-T187

Other Therapeutic Agents

Study Details

Brief summary:

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Study ID

NCT06598800

Start date

Oct 18, 2024

Status verified date

Aug, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).
5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
6. Adequate organ function.

Exclusion Criteria:

1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
4. History of interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
6. Active hepatitis C.
7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

153 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

experimental: Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration

Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.

experimental: Phase 1a Part C: Safety Expansion

BG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.

experimental: Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration

Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.

experimental: Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents

Participants will receive BG-T187 in combination with Other Therapeutic Agents.

Interventions

Drug: BG-T187

administered subcutaneously

Other Therapeutic Agents

administered intravenously

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 2 years ]
  • Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187 [ Time Frame: Approximately 2 years ]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187 [ Time Frame: Approximately 2 years ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  • Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Locations

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601-1915

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Washington University, St Louis, Division of Oncology

Recruiting

Madison, Wisconsin, United States, 53708-8056

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Advanced Solid Tumors
  • First-in-human
  • BG-T187
  • EGFR
  • c-MET

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-07.