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Clinical Trials in Australia / NCT07849231
Recruiting Phase 1

A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms

NCT07849231 · tracked via the Priya Life Science Australia tracker
Sponsor
Damora Therapeutics
Phase
Phase 1
Started
2026-09
Last updated
2026-10-07

Condition(s) studied

Myeloproliferative Neoplasms (MPNs)

Investigational drug(s) / intervention(s)

DMR-001Ruxolitinib →

DMR-001: DMR-001 will be administered at protocol defined dose at a frequency of every 4 weeks.

Ruxolitinib: Ruxolitinib will be administered according to Prescribing Information/SmPC.

Study summary

This is a multi-center, open-label, Phase 1/1b study designed to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of DMR-001 monotherapy in adult participants with CALR-mutated essential thrombocythemia (ET) and myelofibrosis (MF), and of DMR-001 in combination with ruxolitinib in participants with CALR-mutant MF.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and the protocol. * Diagnosis/confirmation of ET or MF as defined in the protocol. * Documented CALR exon-9 mutation. * Willingness to undergo bone marrow biopsy and aspiration per the Schedule of Assessments. Exclusion Criteria: * Presence of any malignancy unless participant has been disease free for at least 2 years. * History of major bleeding or thrombosis within the last 3 months prior to study enrollment. * Prior hematopoietic stem cell transplantation or donor leukocyte infusion, or such transplantation or infusion is planned. * Participants with laboratory values exceeding protocol defined thresholds. * History of clinically significant or uncontrolled cardiac disease. * Active HBV, HCV or HIV. * Known hypersensitivity to DMR-001 or ruxolitinib or any of their components. Other protocol defined Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

  • To evaluate the safety and tolerability of DMR-001 & determine the MTD, RDE(s), and/or recommended Phase 2 dose(s) in participants with CALR-mutant MPNs, when administered as monotherapy or in combination with ruxolitinib — Up to 672 days
    Incidence and severity of AEs and SAEs, including DLTs and AEs resulting in dose modification (interruption, reduction, or discontinuation)

Trial sites (4)

FacilityCityRegionStatus
Site AU08 Liverpool New South Wales Not Yet Recruiting
Site AU09 Sydney New South Wales Recruiting
Site AU06 Melbourne Victoria Not Yet Recruiting
Site AU03 Melbourne Victoria Not Yet Recruiting

On this site

📄 Jakafi (ruxolitinib) drug profile →

Other trials for the same condition

A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms Recruiting
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07849231 on ClinicalTrials.gov ↗ ← All trials in Australia