Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-88549968 · 1 trial · 1 indication
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events \[ICANS\]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only) | EXPERIMENTAL | In dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. Additional Cohorts may be added to assess different formulation or delivery methods. In dose expansion (Part 2, Part 2b \[US only\]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b \[US only\]). |
| Name | Type | Description |
|---|---|---|
| JNJ-88549968 | DRUG | JNJ-88549968 will be administered. |
| Ruxolitinib | DRUG | For US sites: Ruxolitinib will be administered for participants with MF only. |
| Momelotinib | DRUG | For US sites: Momelotinib will be administered for participants with MF only. |
Inclusion Criteria: * Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent * Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET)...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
JNJ-88549968 is an investigational small molecule being developed by Johnson & Johnson for the treatment of calreticulin (CALR)-mutated myeloproliferative neoplasms, a group of blood cancers. It is in Phase 1 clinical development and is designed for patients with this specific biomarker-defined disease.
JNJ-88549968 is being studied for the treatment of calreticulin (CALR)-mutated myeloproliferative neoplasms, which fall under the broader category of neoplasms. It is an investigational therapy and has not been approved for any indication. The Phase 1 study enrolls adults aged 18 years and older.
JNJ-88549968 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is running the Phase 1 program for the asset in CALR-mutated myeloproliferative neoplasms.
JNJ-88549968 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial is currently active and recruiting participants.
JNJ-88549968 is being evaluated in one Phase 1 trial, NCT06150157, titled A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms. The trial is recruiting up to 300 participants across the United States, Canada, China, France, Germany, Israel, Italy, Japan, Spain, and the United Kingdom.
Yes. JNJ-88549968 is being studied in a biomarker-selected population, specifically patients with calreticulin (CALR)-mutated myeloproliferative neoplasms. The Phase 1 trial NCT06150157 enrolls adults 18 years and older of all sexes and does not include healthy volunteers.