NCT07138196

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
42mo left

Started Dec 2025

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Oct 2029

First Submitted

Initial submission to the registry

August 11, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 23, 2025

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2029

Expected
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

August 11, 2025

Last Update Submit

December 24, 2025

Conditions

Chronic Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Dose-Limiting Toxicities (DLTs)

    DLTs assessed for each dose level

    Cycle 1 (28 Days)

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

    AEs and SAEs assessed for each dose level.

    Cycle 1 (28 Days)

Secondary Outcomes (1)

  • Pharmacokinetics (PK)

    Estimated up to Cycle 1 (28 Days)

Other Outcomes (3)

  • Objective Response Rate (ORR)

    Cycle 7 Day 1 (One Cycle is 28 Days)

  • Duration of Response (DOR)

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

  • Failure-Free Survival (FFS)

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

Study Arms (1)

Adrixetinib (Q702)

EXPERIMENTAL

Escalating doses of adrixetinib in 28 day cycles.

Drug: Adrixetinib

Interventions

AdrixetinibDRUG

Administered orally

Also known as: Q702
Adrixetinib (Q702)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Central Study Contacts

Qurient Clinical Trial Information

CONTACT

+82-31-8060-1610clinicaltrial_info@qurient.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 22, 2025

Study Start

December 23, 2025

Primary Completion (Estimated)

October 23, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

ES(8)