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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02908906 | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers | PHASE1 | ACTIVE NOT_RECRUITING | 234 | — | — | Nov 21, 2016 | Dec 31, 2026 | Jun 8, 2026 | 20 | United States, Moldova +5 |
Frequency and severity of dose-limiting toxicity will be reported.
Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.
| Arm | Type | Description |
|---|---|---|
| JNJ-63723283 | EXPERIMENTAL | In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous \[SC\] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4. |
| Name | Type | Description |
|---|---|---|
| JNJ-63723283 | DRUG | JNJ-63723283 will be administered by IV infusion or SC injection or infusion. |
Inclusion Criteria: * Parts 1-4: Have an Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1 * Parts 1-4: Has thyroid function laboratory values within normal range * Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test * Parts 1-4: Willing and ab...