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
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.
Detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Arms & interventions
- DrugDrug: BG-T187
administered subcutaneously
- DrugOther Therapeutic Agents
administered intravenously
Outcome measures
Primary
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Approximately 2 years
Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187
MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively.
Time frame: Approximately 2 years
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187
RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
Time frame: Approximately 2 years
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 2 years
Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents
R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available
Time frame: Approximately 2 years
Secondary
Phase 1a: ORR
Time frame: Approximately 2 years
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
Time frame: Approximately 2 years
Phase 1b: Progression Free Survival (PFS)
Time frame: Approximately 2 years
Phase 1a: Maximum observed plasma concentration (Cmax) of BG-T187
Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187
Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Terminal Half-Life (t1/2) of BG-T187
Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1a: Time to maximum plasma concentration (Tmax) of BG-T187
Time frame: From Cycle 1 to Cycle 3 (each cycle is 28 days)
Phase 1b: Number of Participants with AEs and SAEs
Time frame: Approximately 2 years
Eligibility criteria
Study locations (4)
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1915
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Next Virginia
Fairfax, Virginia, 22031
Washington University, St Louis, Division of Oncology
Madison, Wisconsin, 53708-8056