At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- JNJ-88549968 (drug), Ruxolitinib (drug), Momelotinib (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2023-12-20
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for neoplasms
- • Phase1 - 300 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neoplasms
Where?
- • London - University College London Hospitals Nhs Foundation Trust
- • London - Guy's and St Thomas' Hospital
- • Oxford - Churchill Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the...
- ✓Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
- ✓Participants with ET and MF with risk characteristics as described in the protocol
- ✓Have an activity scale (ECOG) performance status grade of less than or equal to (\<=) 2
- ✓For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK)...
Who cannot take part
- ✗Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
- ✗Prior solid organ transplantation
- ✗Either of the following regarding hematopoietic stem cell transplantation:
- ✗Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of...
- ✗Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
See the full criteria
Where Is This Study? (3 UK sites)
University College London Hospitals Nhs Foundation Trust
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Guy's and St Thomas' Hospital
London SE1 9RT, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
