A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors

BeiGene

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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. 5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥…

Interventions

Drug
Drug: BG-T187
administered subcutaneously
Drug
Other Therapeutic Agents
administered intravenously

Locations (26)

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