Recruiting NCT06034002
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INCA033989, Ruxolitinib.
- Who it may be relevant to
- Registry conditions: Myeloproliferative Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Overview
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms.
Interventions
- Drug INCA033989
INCA033989 will be administered at protocol defined dose. - Drug Ruxolitinib
Rux will be administered according to Prescribing Information/SmPC.
Primary outcome measures
- Number of participants with Dose Limiting Toxicities (DLTs) [Time frame: Up to 28 days]
- Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 3 years and 60 days]
Secondary outcome measures (12)
- Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF [Time frame: Up to 3 years and 60 days]
- Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol [Time frame: Up to 24 weeks]
- Participants with symptomatic anemia: Anemia Response as defined in the protocol [Time frame: Up to 24 weeks]
- Participants with ET: Response using the revised IWG-MRT and ELN response criteria for ET [Time frame: Up to 3 years and 60 days]
- Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation [Time frame: Up to 3 years and 60 days]
- Percentage of participants achieving ≥ 50% reduction from baseline in total symptom score (TSS) [Time frame: Week 12 and Week 24]
- Mean change from baseline in TSS [Time frame: Week 12 and Week 24]
- Mean change in disease-related allele burden [Time frame: Up to 3 years and 60 days]
- Pharmacokinetics Parameter: Cmax of INCA033989 alone or for the combination of INCA033989 with ruxolitinib [Time frame: Up to 3 years and 60 days]
- Pharmacokinetics Parameter: Tmax of INCA033989 alone or for the combination of INCA033989 with ruxolitinib [Time frame: Up to 3 years and 60 days]
- Pharmacokinetics Parameter: Cmin of INCA033989 alone or for the combination of INCA033989 with ruxolitinib [Time frame: Up to 3 years and 60 days]
- Pharmacokinetics Parameter: AUC(0-t) of INCA033989 alone or for the combination of INCA033989 with ruxolitinib [Time frame: Up to 3 years and 60 days]
Eligibility criteria
Inclusion criteria
- Life expectancy > 6 months.
- Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
- Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
- Participants with MF or ET as defined in the protocol.
Exclusion criteria
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
- Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
- Participants with laboratory values exceeding the protocol defined thresholds.
- Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
- Active invasive malignancy over the previous 2 years.
- History of clinically significant or uncontrolled cardiac disease.
- Active or chronic HBV or active HCV or known history of HIV.
- Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
- Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- City of Hope Medical Center — Duarte
- Stanford Cancer Institute — Palo Alto
- University of Miami Health System — Miami
- The University of Kansas Cancer Center — Westwood
- Johns Hopkins Hospital — Baltimore
- Dana Farber Cancer Institute — Boston
- Washington University School of Medicine — St Louis
- Icahn School of Medicine At Mount Sinai — New York
- … and 5 more centers
Identifiers
NCT: NCT06034002 · INCA33989-102