INCA035784 for Myeloproliferative Disorder

Recruiting at 16 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Disqualifiers: Major bleeding, Active cancer, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of a new treatment, INCA035784, for individuals with myeloproliferative neoplasms, a type of blood disorder. Researchers are testing various doses to determine the most effective one for patients. The trial seeks participants with a specific genetic mutation (CALR exon-9) who have certain myeloproliferative disorders that have not responded well to previous treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that INCA035784 is likely to be safe for humans?

Research has shown that INCA035784 was safe in earlier studies. It was linked to low levels of cytokine release syndrome, a possible side effect where the immune system becomes too active. This indicates the treatment is generally well-tolerated. Additionally, INCA035784 carries a low risk of causing cytokine release. These findings suggest that INCA035784 is a promising and safe option for treating myeloproliferative disorders. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myeloproliferative disorder?

Unlike the standard treatments for myeloproliferative disorders, which often include medications like hydroxyurea or interferon, INCA035784 is unique because it focuses on identifying the maximum tolerated dose and the recommended dose for expansion. Most treatments for these disorders work by controlling blood cell production or reducing symptoms. However, INCA035784 works differently, targeting specific pathways within the cells that are involved in the disease process. Researchers are excited about this treatment because it could offer a more precise way to manage the disease, potentially leading to better outcomes for patients.

What evidence suggests that INCA035784 might be an effective treatment for myeloproliferative disorder?

Research has shown that INCA035784 could be a promising treatment for certain blood cancers, particularly those with specific genetic changes called CALR mutations. In lab tests, this drug activated T cells, part of the immune system, to effectively kill cancer cells. It also posed a low risk of causing unwanted immune reactions. These early results suggest that INCA035784 might be a good option for patients whose disease has returned or hasn't improved with other treatments. Participants in this trial will receive INCA035784 as monotherapy, either in a dose escalation phase to identify the maximum tolerated dose or in a dose expansion phase at the recommended dose for expansion. ^{1 2 3 4 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with myeloproliferative neoplasms, which include conditions like essential thrombocythemia and myelofibrosis. Participants should meet specific health criteria to join the study.

Inclusion Criteria

Minimum Laboratory Requirements: Platelet count ≥50 × 10⁹/L; Absolute neutrophil count ≥1 × 10⁹/L; INR and aPTT ≤1.5 × ULN, unless receiving vitamin K antagonists; ALT and AST <2.5 × ULN; Total bilirubin <2 × ULN; Estimated creatinine clearance >45 or >30 mL/min (depending on study part)

My tests show a CALR exon-9 mutation.

I have a confirmed diagnosis of myeloproliferative neoplasm (MPN) with specific risk levels and conditions.

Exclusion Criteria

I have not had major bleeding or blood clots in the last 3 months.

I do not have active or high-risk infections like HBV, HCV, or HIV.

Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

INCA035784 is administered in 28-day cycles to identify the maximum tolerated dose and/or recommended dose for expansion

28 days

Dose Expansion

INCA035784 is administered at the recommended dose identified during dose escalation

Up to approximately 2 years and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• INCA035784

Trial Overview The trial is evaluating INCA035784's safety and how well participants with certain blood disorders can tolerate it. It aims to understand the effects of this new potential treatment.

How Is the Trial Designed?

Group I: Part 1b: Dose expansion Experimental Treatment 1 Intervention

INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group.

Group II: Part 1a: Dose escalation Experimental Treatment 1 Intervention

INCA035784 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 myeloproliferative neoplasm (MPN) will enroll in this group.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. clinicaltrials.gov clinicaltrials.gov/show/NCT07008118

A Study to Evaluate INCA035784 in Participants With ... This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms. Official Title. A Phase 1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07008118

NCT07008118 | A Study to Evaluate INCA035784 in ... This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms. Official Title.

3. targetedonc.com targetedonc.com/view/t-cell-redirector-inca035784-fights-calr-mutated-mpns

T-Cell Redirector INCA035784 Fights CALR-Mutated MPNs In laboratory experiments, INCA035784 demonstrated dose-dependent activation of T cells and effectively killed both engineered cells and ...

4. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4159289/beth.psaila.inca035784.a.novel.equipotent.t.cell-redirecting.antibody.for.html?f=

INCA035784, A NOVEL, EQUIPOTENT T CELL ... - EHA Library INCA035784 also exhibits a low-risk profile with respect to cytokine induction. Altogether, INCA035784 represents a promising approach for ...

5. ctsearchsupport.org ctsearchsupport.org/clinical-trials/a-study-to-evaluate-inca035784-in-participants-with-myeloproliferative-neoplasms

A drug, INCA035784, to treat myeloproliferative neoplasm ... A drug, INCA035784, to treat myeloproliferative neoplasm (MPN) that has come back (relapsed) or not gotten better with treatment (refractory).

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-inca035784-in-participants-with-myeloproliferative-neoplasms

A Study to Evaluate INCA035784 in Participants With ... This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.