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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04089527 | Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma | PHASE1 | COMPLETED | 24 | — | — | Oct 24, 2019 | Oct 25, 2021 | Feb 1, 2022 | 5 | France, Spain |
is defined as any toxicities occurring within the DLT assessment unless the event can clearly be determined to be unrelated to CC-95775.
dose level that could be given such that the estimated DLT probability is closest to 25%.
The dose that is higher than MTD
Number of participants with adverse event. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study
| Arm | Type | Description |
|---|---|---|
| CC-95775 | EXPERIMENTAL | Escalating dose finding part A of study and extension Part B of the study. In Part A, subjects will be treated with oral capsules of CC-95775 with a schedule of 4d on/ 24d off (Q4W) and a starting dose of 100 mg/day on a 28-day cycle. Dose increments between cohorts will not exceed 100% of the dose in previous cohort. Patients in Part B will be treated with a schedule of 4d on/24d off (Q4W) at the Maximum tolerated dose (MTD) established from Part A. |
| Name | Type | Description |
|---|---|---|
| CC-95775 | DRUG | CC-95775 |
Inclusion Criteria: Subjects must satisfy the criteria below to be enrolled in dose escalation (Part A) and in dose expansion (Part B) of this study. 1. Men and women ≥ 18 years of age, at the time of signing the ICF. 2. Subject must understand and voluntarily sign an ICF prior to any study-specif...