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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07226349 | A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors | PHASE1 | RECRUITING | 105 | — | — | Dec 11, 2025 | Nov 1, 2028 | Jun 3, 2026 | 21 | United States, Australia +2 |
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including physical examination findings, electrocardiogram results, laboratory values, and AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria.
MTD is determined based on a target for dose-limiting toxicities. MAD is defined as the maximum administered dose, and it is used when MTD is not reached.
The RDFE(s) will be determined from safety, tolerability, pharmacokinetic, pharmacodynamic biomarker(s), preliminary antitumor activity, and any other relevant data that are obtained from the dose escalation phase.
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 using RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy. |
| Phase 1a, Part B: Dose Escalation, BG-75098 Combination | EXPERIMENTAL | Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination | EXPERIMENTAL | Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant. |
| Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy | EXPERIMENTAL | Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a. |
| Name | Type | Description |
|---|---|---|
| BG-75098 | DRUG | Administered orally. |
| BGB-43395 | DRUG | Administered orally. |
| Fulvestrant | DRUG | Administered by intramuscular injection. |
Inclusion Criteria: * Participants must have measurable disease as assessed by RECIST v1.1. * Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have adequate organ function. * Dose Escalation Part A: Participants with histolo...
| 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 |