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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03994601 | An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers | PHASE1 | COMPLETED | 219 | — | — | Sep 6, 2019 | Aug 31, 2024 | Jan 20, 2026 | 40 | United States, Argentina +5 |
Safety releated events for Cohorts 1A, 1B and 2B.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Arm A: BMS-986288 Monotherapy | EXPERIMENTAL | - |
| Arm B: BMS-986288 in combination with Nivolumab | EXPERIMENTAL | - |
| Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986288 | DRUG | Specified dose on specified days |
| Nivolumab | DRUG | Specified dose on specified days |
| Regorafenib | DRUG | Specified dose on specified days |
Inclusion Criteria: * Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Received, and t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |