BG-T187 alone and with other cancer medicines for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1a/1b multicenter trial uses dose-escalation followed by dose-expansion cohorts to test BG-T187 alone and in combination with other therapeutic agents. The primary goals are to determine safety, tolerability, pharmacokinetics, and pharmacodynamics and to identify recommended dosing, with secondary endpoints including preliminary antitumor activity assessed by RECIST v1.1. Eligible participants are adults with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have received prior therapy, have ECOG performance status ≤1, measurable disease per protocol, and adequate organ function. Study visits include dosing, safety monitoring, PK/PD sampling, and tumor assessments at participating U.S. cancer centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• The University of Texas Md Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Next Oncology Virginia
  Fairfax, Virginia, United States Recruiting
• Washington University, St Louis, Division of Oncology
  Madison, Wisconsin, United States Recruiting
• Blacktown Cancer and Haematology Centre
  Blacktown, New South Wales, Australia Recruiting
• Macquarie University
  North Ryde, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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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.