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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06625593 | A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 168 | — | — | Dec 9, 2024 | Dec 31, 2026 | May 29, 2026 | 53 | United States, Australia +2 |
Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
RDFE(s) is determined based on relevant data, as available
The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
| Arm | Type | Description |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation and Safety Expansion | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy |
| Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion | EXPERIMENTAL | Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation |
| Phase 1b: Dose Expansion | EXPERIMENTAL | Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications |
| Name | Type | Description |
|---|---|---|
| BG-C137 | DRUG | Administered intravenously |
| Anticancer Agents | DRUG | Administered intravenously or orally |
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid tumors. 2. Life expectancy of ≥ 3 months. 3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not t...
| 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 |