Status:
RECRUITING
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
Lead Sponsor:
BeiGene
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 prelim...
Eligibility Criteria
Inclusion
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
- ≥ 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.
- Adequate organ function.
Exclusion
- Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
- Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
- 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).
- 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.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
- Active hepatitis C.
- 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.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT06598800
Start Date
October 18 2024
End Date
September 30 2028
Last Update
January 6 2026
Active Locations (21)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601-1915
2
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030-4009
3
Next Virginia
Fairfax, Virginia, United States, 22031
4
Washington University, St Louis, Division of Oncology
Madison, Wisconsin, United States, 53708-8056