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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06596473 | A Study of BG-C477 in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 310 | — | — | Oct 3, 2024 | Dec 31, 2027 | Jun 4, 2026 | 52 | United States, Australia +5 |
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria.
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
RDFE of BG-C477 monotherapy will be determined based upon available data.
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
| Arm | Type | Description |
|---|---|---|
| Phase 1a: BG-C477 Monotherapy Dose Escalation | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy. |
| Phase 1a: BG-C477 Monotherapy Safety Expansion | EXPERIMENTAL | Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy. |
| Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization | EXPERIMENTAL | Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a. |
| Phase 1b Part B: Combination Therapy Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab. |
| Name | Type | Description |
|---|---|---|
| BG-C477 | DRUG | Administered intravenously. |
| Tislelizumab | DRUG | Administered intravenously. |
| Chemotherapy | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information. |
Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastati...
| 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 |