BridgeMD
New treatment option for Myeloproliferative Neoplasms
Official title A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT07008118
What this study is testing
What is INCA035784?
INCA035784 is an investigational medicine, being studied as a potential treatment for myeloproliferative neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older at the time of signing the ICF
- ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)
- Documented CALR exon-9 mutation
- Confirmed diagnosis of MPN according to the 2022 ICC criteria:
- DIPSS+ intermediate-2/high-risk MF with prior JAKi, \<20% blasts, and measurable spleen
You likely can't join if
- Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
- Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
- Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate...
- Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose. Other protocol-defined...
See the full eligibility criteria
- Age 18 years or older at the time of signing the ICF
- ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)
- Documented CALR exon-9 mutation
- Confirmed diagnosis of MPN according to the 2022 ICC criteria:
- DIPSS+ intermediate-2/high-risk MF with prior JAKi, \<20% blasts, and measurable spleen
- High-risk ET with platelets \>450×10⁹/L
- Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country)
- No prior stem cell transplant and none planned within 6 months
- Minimum Laboratory Requirements:
- Platelet count ≥50 × 10⁹/L
- Absolute neutrophil count ≥1 × 10⁹/L
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN
- Total bilirubin \<2 × ULN
- Estimated creatinine clearance \>45 or \>30 mL/min (depending on study part)
- Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
- Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
- Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)
- Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose. Other protocol-defined Inclusion/Exclusion Criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Palo Alto, California, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
- Sydney, New South Wales, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Palo Alto, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.