Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C9074 · 1 trial · 1 indication
Number of participants with AEs and SAEs (as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] Version \[v\] 5.0),, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively
The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Part A (Monotherapy Dose Escalation) | EXPERIMENTAL | BG-C9074 monotherapy dose escalation |
| Phase 1a: Part B (Monotherapy Safety Expansion) | EXPERIMENTAL | BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated. |
| Phase 1a: Part C (Combination Therapy Dose Escalation) | EXPERIMENTAL | BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE). |
| Phase 1a: Part D (Japan Cohort) | EXPERIMENTAL | A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors |
| Phase 1b: Monotherapy Dose Expansion | EXPERIMENTAL | The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a. |
| Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab) | EXPERIMENTAL | This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase. |
| Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab) | EXPERIMENTAL | This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule. |
| Name | Type | Description |
|---|---|---|
| BG-C9074 | DRUG | administered by intravenous infusion |
| Tislelizumab | DRUG | administered by intravenous infusion |
| Bevacizumab | DRUG | administered by intravenous infusion |
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Participants with selected histologically or cytologically confirmed advan...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BG-C9074 is an investigational small molecule antibody-drug conjugate being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BG-C9074 targets B7-H4, a protein involved in tumor immune evasion. As an antibody-drug conjugate, it is designed to deliver a cytotoxic agent to B7-H4-expressing tumor cells. This mechanism is being evaluated in patients with advanced solid tumors.
BG-C9074 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in advanced solid tumors.
BG-C9074 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The ongoing Phase 1a/1b trial is recruiting participants to assess the drug alone and in combination with other anticancer therapies.
BG-C9074 is being studied in a Phase 1a/1b first-in-human trial with the identifier NCT06233942. This open-label, controlled study enrolls approximately 308 patients with advanced solid tumors across the United States, Australia, Brazil, China, and Japan. The trial is currently recruiting participants aged 18 years and older.
BG-C9074 is a distinct investigational antibody-drug conjugate targeting B7-H4. While other drugs may also target B7-H4, BG-C9074 is a unique asset developed by BeOne Medicines Ltd. with its own clinical trial program and formulation.