Recruiting PHASE1 Chronic Graft-Versus-Host Disease

Compares treatment options for Chronic Graft-Versus-Host Disease

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

ClinicalTrials.gov ID: NCT07138196

What this study is testing

What is Adrixetinib?

Adrixetinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic graft-versus-host disease.

Also referred to as Q702.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • people who are allogeneic HSCT recipients with moderate or severe active cGVHD requiring systemic immune suppression.
  • people 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...
  • Adequate organ and bone marrow functions.
  • Karnofsky Performance Scale of ≥ 60.

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Barcelona, Spain
  • Madrid, Spain
  • Majadahonda, Spain
  • Murcia, Spain
  • Pamplona, Spain
  • Santander, Spain
  • Seville, Spain
  • Valencia, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Barcelona, Spain; Madrid, Spain; Majadahonda, Spain; Murcia, Spain; Pamplona, Spain; Santander, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.