Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06233942 | Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 308 | — | — | Apr 12, 2024 | May 15, 2028 | Jun 5, 2026 | 37 | United States, Australia +3 |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |