Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]CC-90001, BMS-986360
CC-90001 · 3 trials · 3 indications
Estimation of AUC calculated from time zero to the last measured time point
Estimation of AUC calculated from time zero to infinity
Estimation of observed maximum plasma concentration
Estimation of time to Cmax
Estimation of terminal elimination half-life
Estimation of apparent clearance of drug from plasma after extravascular administration
Estimation of apparent volume of distribution during the terminal phase
Number of subjects with adverse events
Number of subjects experiencing dose interruptions, reductions, and discontinuation of CC-90001 secondary to an AE
Complete Physical Examinations
Heart rate (HR), respiratory rate, blood pressure (BP), and body temperature
| Arm | Type | Description |
|---|---|---|
| BMS-986360 | EXPERIMENTAL | - |
| BMS-986360 + Docetaxel | EXPERIMENTAL | - |
| BMS-986360 + Nivolumab | EXPERIMENTAL | - |
| BMS-986360 + Capecitabine | EXPERIMENTAL | - |
| Administration of CC-90001 | EXPERIMENTAL | Single oral dose of 200 mg of CC-90001 |
| Low dose CC-90001 | EXPERIMENTAL | Low dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks |
| High dose CC-90001 | EXPERIMENTAL | High-dose (200 mg) CC-90001 administered orally Once Daily (QD) for 12 continuous weeks |
| Name | Type | Description |
|---|---|---|
| BMS-986360 | DRUG | Specified dose on specified days |
| Docetaxel | DRUG | Specified dose on specified days |
| Nivolumab | DRUG | Specified dose on specified days |
| Capecitabine | DRUG | Specified dose on specified days |
| CC-90001 | DRUG | CC-90001 |
Inclusion Criteria: * Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), micros...
CC-90001 is an investigational small molecule developed by Bristol-Myers Squibb Company. It has been studied in Phase 1 clinical trials in hepatic impairment and pulmonary fibrosis. It is not approved and remains in clinical development.
CC-90001 was studied in a Phase 1 pharmacokinetics trial in adults with mild, moderate, and severe hepatic impairment compared with healthy subjects. The trial, NCT03742882, enrolled 40 participants in the United States and is completed. CC-90001 is investigational and not approved for any use.
CC-90001 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 studies of CC-90001 in hepatic impairment and pulmonary fibrosis.
CC-90001 is in Phase 1 development. Both of its listed clinical trials are Phase 1 studies, and both are completed. The drug is investigational and has not been approved by the FDA for any indication.
CC-90001 has been evaluated in two completed Phase 1 trials. NCT03742882 assessed its pharmacokinetics in adults with mild, moderate, and severe hepatic impairment versus healthy subjects, enrolling 40 participants. NCT02510937 was a safety and pharmacokinetics study in subjects with pulmonary fibrosis, enrolling 16 participants in the United States and Australia.
Yes. [14C]CC-90001 is an alternative name for CC-90001, referring to the carbon-14 labeled form of the compound used in research. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb Company.