Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-92480 · 7 trials · 3 indications
Maximum plasma concentration of drug
Time to maximum plasma concentration
Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to the last observable concentration
Terminal elimination half-life
Apparent total plasma clearance
Apparent volume of distribution
Lag time between time of administration and start of absorption
Maximum plasma concentration of drug
Ratio of maximum plasma concentration of drug
Area under the plasma concentration-time curve from time zero to infinity
Ratio of area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to the last observable concentration
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time to maximum plasma concentration
Terminal elimination half-life
Apparent total plasma clearance
Apparent volume of distribution
Lag time between time of administration and start of absorption
The total recovery of radioactivity (RA) will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).
Time to reach maximum total radioactivity or concentration of CC-92480 and its metabolites
Maximum total radioactivity or concentration of CC-92480 and its metabolites
Area under the concentration-time curve from time zero to the last measured time point
Area under the concentration-time curve from time zero extrapolated to infinite time
Apparent oral clearance
Apparent volume of distribution
Terminal elimination half-life
The percentage of the administered dose attributed to CC-92480 and its metabolites in urine and feces
Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Area under the plasma concentration-time curve from time zero to 24 hours postdose
Terminal half-life
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Terminal half-life
| Arm | Type | Description |
|---|---|---|
| Part 1 Arm A: Dose Finding | EXPERIMENTAL | - |
| Part 1 Arm B: Dose Finding | EXPERIMENTAL | - |
| Part 1 Arm C: Dose Finding | EXPERIMENTAL | - |
| Part 2 Arm D: Dose Expansion | ACTIVE_COMPARATOR | - |
| Part 2 Arm E: Dose Expansion | EXPERIMENTAL | - |
| Part 2 Arm G: Dose Expansion | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Part 3 | EXPERIMENTAL | - |
| CC-92480-02 (Formulation A) with Placebo | EXPERIMENTAL | CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions. |
| CC-92480 (Formulation B)- fasted condition | EXPERIMENTAL | A single oral dose of CC-92480 (Formulation B) administered under fasted conditions. |
| CC-92480-02 (Formulation A) - fasted condition | EXPERIMENTAL | A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions. |
| CC-92480 (Formulation B) - Low-fat meal | EXPERIMENTAL | A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal). |
| CC-92480-02 (Formulation A) - high-fat meal | EXPERIMENTAL | A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal). |
| Administration of [14C]-CC-92480 | EXPERIMENTAL | \[14C\]-CC-92480 will be administered as an oral solution. A single oral dose of \[14C\]-CC-92480, containing approximately 2 μCi of radioactivity, will be administered on Day 1 under fasted conditions. |
| Administration of CC-92480 and Rabeprazole | EXPERIMENTAL | Test Formulation CC-92480 and Reference Formulation will be administered orally at 1.6 mg. Rabeprazole will be administered orally at 40 mg. |
| Cohort A: CC-92480 with bortezomib and dexamethasone | EXPERIMENTAL | - |
| Cohort C: CC-92480 with carfilzomib and dexamethasone | EXPERIMENTAL | - |
| Cohort H: CC-92480 with elotuzumab and dexamethasone | EXPERIMENTAL | - |
| Cohort I: CC-92480 with isatuximab and dexamethasone | EXPERIMENTAL | - |
| Cohort D: CC-92480 with bortezomib and dexamethasone | EXPERIMENTAL | - |
| Cohort F: CC-92480 with carfilzomib and dexamethasone | EXPERIMENTAL | - |
| Cohort J: CC-92480 with elotuzumab and dexamethasone | EXPERIMENTAL | - |
| Cohort K: CC-92480 with isatuximab and dexamethasone | EXPERIMENTAL | - |
| Cohort G: CC-92480 with bortezomib and dexamethasone | EXPERIMENTAL | - |
| Subcohort B1: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Subcohort B2: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Subcohort B3: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Subcohort E1: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Subcohort E2: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Subcohort E3: CC-92480 with daratumumab and dexamethasone | EXPERIMENTAL | - |
| Administration of CC-92480 - Part 1 | EXPERIMENTAL | dose escalation |
| Administration of CC-92480 under fasted conditions - Part 2 | EXPERIMENTAL | Food effect |
| Administration of CC-92480 under fed conditions - Part 2 | EXPERIMENTAL | food effect |
| Name | Type | Description |
|---|---|---|
| CC-92480 | DRUG | Specified dose on specified days |
| Tazemetostat | DRUG | Specified dose on specified days |
| BMS-986158 | DRUG | Specified dose on specified days |
| Trametinib | DRUG | Specified dose on specified days |
| Dexamethasone | DRUG | Specified dose on specified days |
| Rifampin | DRUG | Specified dose on specified days |
| Itraconazole | DRUG | Specified dose on specified days |
| Digoxin | DRUG | Specified dose on specified days |
| Rosuvastatin | DRUG | Specified dose on specified days |
| Placebo | OTHER | Oral |
| [14C]-CC-92480 | DRUG | Oral |
| Rabeprazole | DRUG | Rabeprazole |
| Bortezomib | DRUG | Specified dose on specified days |
| Daratumumab | DRUG | Specified dose on specified days |
| Carfilzomib | DRUG | Specified dose on specified days |
| Elotuzumab | DRUG | Specified dose on specified days |
| Isatuximab | DRUG | Specified dose on specified days |
Inclusion Criteria: * Relapsed or refractory multiple myeloma (MM) and must: 1. Have documented disease progression during or after their last myeloma therapy. 2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide ...
CC-92480 is an investigational small molecule being studied for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). It is also used in clinical trials involving healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
CC-92480 is being developed by Bristol-Myers Squibb Company (BMY). The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple myeloma and healthy volunteer studies.
CC-92480 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to determine the recommended dose and regimen for multiple myeloma.
CC-92480 is being studied in several Phase 1 trials, including NCT03989414 in relapsed or refractory and newly diagnosed multiple myeloma, and healthy volunteer studies NCT04560738, NCT04839809, and NCT05389722. These trials assess safety, metabolism, drug interactions, and formulations.
CC-92480 is also known as mezigdomide. It is a cereblon E3 ligase modulator being investigated for multiple myeloma. The drug is being developed by Bristol-Myers Squibb and is currently in Phase 1 clinical trials.