Clinical Trials in Spain / NCT07138196
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
Condition(s) studied
Chronic Graft-Versus-Host Disease
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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