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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04121286 | A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China | PHASE1 | COMPLETED | 17 | — | — | Jul 14, 2020 | Jun 17, 2022 | May 20, 2025 | 5 | China |
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3312.
Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in \<33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
| Arm | Type | Description |
|---|---|---|
| JAB-3312 | EXPERIMENTAL | JAB-3312 will be administered orally once daily in 21 days treatment cycles. |
| Name | Type | Description |
|---|---|---|
| JAB-3312 | DRUG | JAB-3312 will be supplied as 0.25 mg, 1.0 mg and 4.0 mg capsules. |
Inclusion Criteria: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progresse...