A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06150157
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.

Key Dates

First listed
Nov 29, 2023
Start date
Dec 20, 2023
Status verified
Sep 2026
Primary completion
Dec 4, 2026
Completion
Jun 14, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)
    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 \[US only\]).

Primary Outcome Measure

Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Approximately up to 35 days after first dose of study treatment ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer CenterAuroraColorado80045-
Moffit Cancer centerTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
University of MichiganAnn ArborMichigan48109-
Start MidwestGrand RapidsMichigan49546-
START New JerseyEast BrunswickNew Jersey08816-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Montefiore Medical CenterThe BronxNew York10467-
Levine Cancer InstituteCharlotteNorth Carolina28204-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Prisma HealthGreenvilleSouth Carolina29605-
Sarah Cannon Cancer InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center· Aurora, COMoffit Cancer center· Tampa, FLEmory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MIStart Midwest· Grand Rapids, MI

Related Studies