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NCT Number: NCT07138196

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

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).

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Clinic de Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrixetinib

Drug

Administered orally

Other names: Q702

Primary outcomes

  1. Number of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Cycle 1 (28 Days)

    DLTs assessed for each dose level

  2. Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)

    Time frame: Cycle 1 (28 Days)

    AEs and SAEs assessed for each dose level.

Secondary outcomes

  1. Pharmacokinetics (PK)

    Time frame: Estimated up to Cycle 1 (28 Days)

    Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites

Other outcomes

  1. Objective Response Rate (ORR)

    Time frame: Cycle 7 Day 1 (One Cycle is 28 Days)

    Proportion of subjects with CR or PR by Cycle 7 Day 1 using Organ-specific response rate based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD

  2. Duration of Response (DOR)

    Time frame: First CR or PR until documented PD, start of new therapy or death (Estimated up to 24 months)

    DOR defined as the time from best response of PR or CR until documented progression of cGVHD, start of new therapy, or death for any reason

  3. Failure-Free Survival (FFS)

    Time frame: Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months)

    FFS is defined as the time from study enrollment (first date of Q702 treatment) to addition of another systemic therapy for cGVHD, relapse of underlying malignancy, or death whichever is earlier.

Study contacts

Contact information is provided by the study sponsor or research team.

Qurient Clinical Trial Information

CONTACT

[email protected]

+82-31-8060-1610

Sponsors and collaborators

Lead sponsor

Qurient Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 22, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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