Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986178 · 1 trial · 1 indication
The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.
The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | * BMS-986178 at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 2: Dose Escalation and Expansion | EXPERIMENTAL | * BMS-986178 in combination with Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 3: Dose Escalation and Expansion | EXPERIMENTAL | * BMS-986178 in combination with Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 4: Dose Schedule and Exploration | EXPERIMENTAL | * BMS-986178/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 5: Dose Schedule and Exploration | EXPERIMENTAL | * BMS-986178/Ipilimumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 6: Dose Safety and Expansion | EXPERIMENTAL | * BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 7: Dose Safety and Expansion | EXPERIMENTAL | * BMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals * Enrollment is closed for this arm |
| Part 8: Dose Exploration | EXPERIMENTAL | * BMS-986178/Nivolumab with tetanus vaccine at specified doses and interval * Enrollment is closed for this arm |
| Part 9: Dose Exploration | EXPERIMENTAL | * BMS-986178/Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 1) at specified doses at specified intervals OR Nivolumab/DPV-001 vaccine/cyclophosphamide (cohort 2) at specified doses at specified intervals * Enrollment is open for this arm \[Tumor type triple negative breast cancer (TNBC)\] |
| Name | Type | Description |
|---|---|---|
| BMS-986178 | DRUG | Specified dose on specified days |
| Nivolumab | DRUG | Specified dose on specified days |
| Ipilimumab | DRUG | Specified dose on specified days |
| Tetanus vaccine | BIOLOGICAL | Specified dose on specified days |
| DPV-001 vaccine | BIOLOGICAL | DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: For Part 9 (only arm open for enrollment): * Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapie...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
BMS-986178 is an investigational small molecule being developed by Bristol-Myers Squibb Company for advanced cancer. It was studied as an immuno-therapy agent, both as a single agent and in combination with nivolumab and/or ipilimumab, in participants with solid cancers that were advanced or had spread.
BMS-986178 was studied for the treatment of advanced cancer, specifically solid tumors that are advanced or have spread. It is an investigational agent and is not an approved therapy. The clinical program evaluated it in adult participants with these advanced solid cancers.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-986178. The company sponsored the clinical study of the compound in advanced solid cancers, evaluating it both alone and in combination with nivolumab and/or ipilimumab.
BMS-986178 is in Phase 1 development. It is an investigational small molecule and has not been approved for any indication. The Phase 1 study evaluating it in advanced solid cancers has been completed, and no trials of this agent are currently active.
BMS-986178 was evaluated in one Phase 1 trial, NCT02737475, titled an investigational immuno-therapy study of BMS-986178 by itself or in combination with nivolumab and/or ipilimumab in participants with advanced or spread solid cancers. The trial enrolled 166 participants across the United States, Canada, Israel, Italy, Netherlands, and Spain, and is completed.