Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-63723283 · 2 trials · 2 indications
The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.
Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
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 |
|---|---|---|
| Phase 1a: JNJ-63723283 (Monotherapy) | EXPERIMENTAL | Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM). |
| Phase 1b: Erdafitinib Combination | EXPERIMENTAL | Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM. |
| 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 intravenously. |
| Erdafitinib | DRUG | Erdafitinib will be administered orally. |
Inclusion Criteria: * Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment options. Participants with solid tumor(s) for which anti-PD-1 or anti-PD-L1 a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
JNJ-63723283 is an investigational anti-PD-1 monoclonal antibody being studied for the treatment of advanced cancers, including solid tumors. It is currently in Phase 1 clinical development for oncology indications such as neoplasms.
JNJ-63723283 targets the programmed cell death protein 1 (PD-1) receptor. By binding to PD-1, it is designed to modulate immune responses in the treatment of cancer.
JNJ-63723283 is being developed by Johnson & Johnson, a company listed on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-63723283 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and activity.
JNJ-63723283 is being studied in two Phase 1 trials. NCT02908906 is evaluating the drug in participants with advanced cancers across multiple countries. NCT03547037 is a completed study in Japanese participants with advanced solid cancers, testing the drug alone or with erdafitinib.
Yes, JNJ-63723283 is an anti-PD-1 monoclonal antibody. It is designed to target the PD-1 pathway, which plays a role in immune regulation and cancer progression.