Adrixetinib (Q702) for 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)

This trial will test whether the oral drug Adrixetinib (Q702) is safe and helps adults with moderate or severe active chronic graft-versus-host disease who have not responded to standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qurient Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Adrixetinib
• Locations: 8 sites (Barcelona and 7 other locations)
• Trial ID: NCT07138196 on ClinicalTrials.gov

What this trial studies

This is an open-label Phase 1, dose-escalation study testing Adrixetinib (Q702) in adults with relapsed or refractory active chronic graft-versus-host disease after allogeneic HSCT. The study will primarily measure safety, tolerability, and pharmacokinetics/pharmacodynamics across escalating dose cohorts and will also record preliminary signals of efficacy. Eligible participants must have moderate or severe active cGVHD requiring systemic immunosuppression and adequate organ and marrow function. Treatment and follow-up visits will take place at designated hospital sites in Spain.

Who should consider this trial

Good fit: Adults who received an allogeneic hematopoietic stem cell transplant and have moderate or severe active cGVHD requiring systemic immunosuppression and who are relapsed or refractory to available standard treatments, with adequate organ function and a Karnofsky score ≥60, are the intended candidates.

Not a fit: Patients with evidence of relapse of their original cancer, a recent other malignancy within three years, prior post-transplant CSF1R inhibitor exposure, or inadequate organ function are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If successful, Adrixetinib could offer a new oral treatment option that reduces cGVHD symptoms and steroid dependence for patients who have exhausted standard therapies.

How similar studies have performed: Other targeted agents for steroid-refractory cGVHD such as ruxolitinib and belumosudil have shown clinical benefit, but Adrixetinib itself is a novel agent for this indication and remains unproven.

Eligibility criteria

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

Where this trial is running

Barcelona and 7 other locations

• 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)

Study contacts

• Study coordinator: Qurient Clinical Trial Information

Conditions Chronic Graft-Versus-Host Disease