Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-T187 · 1 trial · 1 indication
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
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.
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
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
R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous Administration | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy. |
| Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous Administration | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy. |
| Phase 1a Part C: Safety Expansion | EXPERIMENTAL | BG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated. |
| Phase 1b: Monotherapy Dose Expansion with Subcutaneous Administration | EXPERIMENTAL | Participants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a. |
| Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic Agents | EXPERIMENTAL | Participants will receive BG-T187 in combination with Other Therapeutic Agents. |
| Name | Type | Description |
|---|---|---|
| Drug: BG-T187 | DRUG | administered subcutaneously |
| Other Therapeutic Agents | DRUG | administered intravenously |
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 Cooperati...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BG-T187 is an investigational small molecule drug being developed by BeOne Medicines Ltd. for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is designed to target EGFR, a receptor involved in cancer cell growth.
BG-T187 is being studied for use in patients with advanced solid tumors. It is an investigational therapy, meaning it is not yet approved for any indication. The ongoing Phase 1 trial is evaluating BG-T187 both as a single agent and in combination with other therapeutic agents.
BG-T187 targets EGFR, a receptor protein that plays a role in cell signaling and tumor growth. By targeting EGFR, the drug aims to interfere with pathways that drive cancer progression. This mechanism is being explored in advanced solid tumors.
BG-T187 is being developed by BeOne Medicines Ltd., a biopharmaceutical company. The company's ticker symbol is ONC. BeOne Medicines is responsible for the clinical development of BG-T187, which is currently in Phase 1 testing.
BG-T187 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial is currently recruiting participants and is designed to evaluate the safety and tolerability of BG-T187 in advanced solid tumors.
BG-T187 is being evaluated in a Phase 1 clinical trial, NCT06598800, titled "Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors." The trial is recruiting and plans to enroll 153 participants across the United States, Australia, China, and South Korea.