A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease
NCT ID: NCT07138196
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2025-12-23
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Adrixetinib (Q702)
Escalating doses of adrixetinib in 28 day cycles.
Adrixetinib
Administered orally
Interventions
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Adrixetinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.
3. Subject must have documented progressive disease as defined by the NIH 2014 consensus criteria, in terms of either organ specific algorithm or global assessment, or active, symptomatic cGVHD for which the treating physician believes that a new line of systemic therapy is required.
4. Adequate organ and bone marrow functions.
5. Karnofsky Performance Scale of ≥ 60.
Exclusion Criteria
2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer.
3. Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment.
4. Female subject who is pregnant or breastfeeding.
5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
18 Years
ALL
No
Sponsors
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Qurient Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Instituto de Investigacion Sanitaria
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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QRNT-012
Identifier Type: -
Identifier Source: org_study_id