A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adrixetinib.
- Who it may be relevant to
- Registry conditions: Chronic Graft-Versus-Host Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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).
Interventions
- Drug Adrixetinib
Administered orally
Primary outcome measures
- Number of Participants with Dose-Limiting Toxicities (DLTs) [Time frame: Cycle 1 (28 Days)]
- Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) [Time frame: Cycle 1 (28 Days)]
Secondary outcome measures (1)
- Pharmacokinetics (PK) [Time frame: Estimated up to Cycle 1 (28 Days)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Exposure to CSF1R inhibitor therapy for any indication after allogeneic transplant.
- 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.
- Female subject who is pregnant or breastfeeding.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 8 centers
- Hospital Clinic de Barcelona — Barcelona
- Hospital General Universitario Gregorio Maranon — Madrid
- Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda
- Hospital Universitario Virgen de la Arrixaca — Murcia
- Clinica Universidad de Navarra — Pamplona
- Hospital Universitario Marques de Valdecilla — Santander
- Hospital Universitario Virgen del Rocio — Seville
- Instituto de Investigacion Sanitaria — Valencia
Identifiers
NCT: NCT07138196 · QRNT-012