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Monoclonal Antibodies
INCA033989 + Ruxolitinib for Myeloproliferative Disorder (LIMBER Trial)
Phase 1
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years and 60 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called INCA033989, alone or with ruxolitinib, in patients with a type of blood cancer. The goal is to find the safest dose and see how well patients can tolerate it. Ruxolitinib is a medication used to treat myelofibrosis.
Who is the study for?
This trial is for people with myeloproliferative neoplasms who have a life expectancy over 6 months and measurable disease. They must be in good enough health to perform daily activities (ECOG score of 0-2) and willing to undergo bone marrow procedures. Participants should not have other active cancers, significant heart issues, or certain infections like HIV.
What is being tested?
The study tests INCA033989 alone or combined with Ruxolitinib to find the safest and most effective doses for treating myeloproliferative neoplasms. It aims to identify any dose-related toxicities and establish recommended dosages for further research.
What are the potential side effects?
While specific side effects are not listed here, common ones may include fatigue, digestive problems, blood count changes, potential liver function alterations, and reactions at the infusion site. The severity can range from mild discomforts to more serious complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years and 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years and 60 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Dose Limiting Toxicities (DLTs)
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Secondary study objectives
Mean change in disease-related allele burden
Participants With ET: Mean change from baseline of total symptom score (TSS)
Participants With ET: Response Rate
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Part 1c: Dose ExpansionExperimental Treatment2 Interventions
INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks.
Group II: Part 1b: Dose Expansion - with TGB-MF SubOpt RExperimental Treatment2 Interventions
INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group.
Group III: Part 1b: Dose Expansion - with MFExperimental Treatment1 Intervention
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.
Group IV: Part 1b: Dose Expansion - with ETExperimental Treatment1 Intervention
INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.
Group V: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt RExperimental Treatment2 Interventions
INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group.
Group VI: Part 1a Dose Escalation Cohort Disease Group A - with MFExperimental Treatment1 Intervention
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF) will enroll in this group.
Group VII: Part 1a Dose Escalation Cohort Disease Group A - with ETExperimental Treatment1 Intervention
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with with essential thrombocythemia (ET) will enroll in this group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1170
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Myeloproliferative Neoplasms (MPNs) include JAK inhibitors like ruxolitinib, which block the overactive JAK-STAT signaling pathway to reduce abnormal blood cell proliferation. Hydroxyurea inhibits DNA synthesis, thereby controlling cell growth, while interferon-alpha modulates the immune system to target malignant cells.
These mechanisms are vital for MPN patients as they help manage symptoms, reduce the risk of complications such as thrombosis, and potentially slow disease progression.
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,576 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have blood cancer, except for ET, PMF, or post-ET MF.I have had an active cancer within the last 2 years.I have a serious heart condition that is not under control.I have been diagnosed with myelofibrosis or essential thrombocythemia.My tests show a CALR exon-9 mutation.I have had or am planning to have a stem-cell transplant.I haven't taken G-CSF, GM-CSF, romiplostim, or eltrombopag in the last 4 weeks.I am not taking strong drugs that affect liver enzymes within 14 days before starting the study.I am willing to have bone marrow tests before and during the study.I haven't taken any cancer treatments within the last 28 days or 5 half-lives, whichever is shorter.I have not had major bleeding or blood clots in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1c: Dose Expansion
- Group 2: Part 1b: Dose Expansion - with ET
- Group 3: Part 1b: Dose Expansion - with TGB-MF SubOpt R
- Group 4: Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R
- Group 5: Part 1a Dose Escalation Cohort Disease Group A - with MF
- Group 6: Part 1a Dose Escalation Cohort Disease Group A - with ET
- Group 7: Part 1b: Dose Expansion - with MF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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