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

NCT ID: NCT07138196

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2029-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Graft-Versus-Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adrixetinib (Q702)

Escalating doses of adrixetinib in 28 day cycles.

Group Type EXPERIMENTAL

Adrixetinib

Intervention Type DRUG

Administered orally

Interventions

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Adrixetinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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Q702

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qurient Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Instituto de Investigacion Sanitaria

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Qurient Clinical Trial Information

Role: CONTACT

Phone: +82-31-8060-1610

Email: [email protected]

Other Identifiers

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QRNT-012

Identifier Type: -

Identifier Source: org_study_id