Ireland
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Recruiting Phase 1

A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease

NCT07138196 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2025-12-23
Last updated
2025-12-30

Condition(s) studied

Chronic Graft-Versus-Host Disease

Investigational drug(s) / intervention(s)

Adrixetinib →

Adrixetinib: Administered orally

Study summary

Open-label, dose escalation study to evaluate safety, tolerability pharmacokinetic and pharmacodynamic activity, and efficacy of Adrixetinib (Q702) in subjects with relapsed or refractory active chronic graft-versus-host disease (cGVHD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression. 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: 1. Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant. 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

Primary outcome measure(s)

  • Number of Participants with Dose-Limiting Toxicities (DLTs) — Cycle 1 (28 Days)
    DLTs assessed for each dose level
  • Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) — Cycle 1 (28 Days)
    AEs and SAEs assessed for each dose level.

Trial sites (8)

FacilityCityRegionStatus
Hospital Clinic de Barcelona Barcelona Spain Recruiting
Hospital General Universitario Gregorio Maranon Madrid Spain Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Spain Recruiting
Hospital Universitario Virgen de la Arrixaca Murcia Spain Recruiting
Clinica Universidad de Navarra Pamplona Spain Recruiting
Hospital Universitario Marques de Valdecilla Santander Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
Instituto de Investigacion Sanitaria Valencia Spain 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 NCT07138196 on ClinicalTrials.gov ↗ ← All trials in Spain