Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-C0979 · 1 trial · 1 indication
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results.
MTD or MAD, defined as the highest dose 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-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available.
RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available.
ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation | EXPERIMENTAL | Participants will receive increasing doses of BG-C0979 as monotherapy. |
| Phase 1a: Monotherapy Safety Expansion | EXPERIMENTAL | Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
| Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion | EXPERIMENTAL | Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
| Phase 1b, Part B: Combination Therapy Expansion | EXPERIMENTAL | Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
| Name | Type | Description |
|---|---|---|
| BG-C0979 | DRUG | Administered by intravenous infusion. |
| Tislelizumab | DRUG | Administered by intravenous infusion. |
Inclusion Criteria: * Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tol...
| 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-C0979 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development as a potential therapy for patients with advanced solid tumors, a type of cancer that has spread or is not responsive to standard treatments.
BG-C0979 targets ADAM9, a protein involved in cancer progression. By targeting ADAM9, BG-C0979 aims to interfere with tumor growth and spread. This mechanism is being evaluated in a first-in-human study for patients with advanced solid tumors.
BG-C0979 is being developed by BeOne Medicines Ltd., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of BG-C0979 in patients with advanced solid tumors.
BG-C0979 is in Phase 1 clinical development. It is an investigational drug currently being studied in a first-in-human trial for advanced solid tumors. The drug has not yet been approved by regulatory authorities and remains in early-stage clinical testing.
BG-C0979 is being evaluated in a Phase 1 clinical trial with the identifier NCT07414836. This first-in-human study is recruiting 84 participants with advanced solid tumors across the United States, Australia, China, and Spain. The trial is currently active and recruiting patients.
BG-C0979 is a small molecule that targets ADAM9, making it an ADAM9 inhibitor. It is being developed as a potential treatment for advanced solid tumors. The drug is currently in Phase 1 clinical trials to assess its safety and preliminary efficacy.