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JNJ-88549968

Phase 1

Neoplasms | Small molecule | Oncology |Johnson & Johnson|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06150157A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative NeoplasmsPHASE1 RECRUITING 220Dec 20, 2023May 12, 2028Jun 5, 202633 United States, Canada +7
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Study Endpoints
Primary Endpoints
Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)
Approximately up to 35 days after first dose of study treatment

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.

Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)
Up to 2 years

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.

Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity
Up to 2 years

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.

Secondary Endpoints
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968
Up to 2 years
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968
Up to 2 years
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate
Up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)EXPERIMENTALIn 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. 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 \[US only\]).
Interventions
NameTypeDescription
JNJ-88549968DRUGJNJ-88549968 will be administered.
RuxolitinibDRUGFor US sites: Ruxolitinib will be administered for participants with MF only.
MomelotinibDRUGFor US sites: Momelotinib will be administered for participants with MF only.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

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)...

Countries:United StatesCanadaChinaFranceGermanyIsraelItalySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06150157Completion: 2028-04-12 → 2028-05-12
LOWJun 5, 2026NCT06150157Completion: 2028-04-12 → 2028-05-12
LOWJun 5, 2026NCT06150157Completion: 2028-04-12 → 2028-05-12
LOWJun 5, 2026NCT06150157Completion: 2028-04-12 → 2028-05-12
LOWMay 26, 2026NCT06150157primaryCompletionDate: changed
LOWMay 24, 2026NCT06150157studyFirstPostDate: changed