NCT07138196RecruitingPhase 1
A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease
A Phase 1b, Open-label Dose Escalation Study to Evaluate the Safety, Pharmacodynamic, Pharmacokinetic and Preliminary Efficacy of Q702 in Subjects With Relapsed or Refractory Active Chronic Graft-versus-Host Disease (cGVHD)
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 23 Dec 2025
- Primary completion date
- 23 Oct 2029
- Lead sponsor
- Qurient Co., Ltd.
- NCT number
- NCT07138196
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 23 Dec 2025 to the primary completion date, 23 Oct 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant.
Other illness
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer.
- Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Other
- Female subject who is pregnant or breastfeeding.
Who the study is looking for
- Subjects who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.
- Subjects with relapsed or refractory active cGVHD who have progressed after all available standard of care treatments.
- 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.
- Adequate organ and bone marrow functions.
- Karnofsky Performance Scale of ≥ 60.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Instituto de Investigacion Sanitaria Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.