Chronic Graft-Versus-Host DiseasePhase 1NCT07138196
A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease
A Phase 1 study testing Adrixetinib in people with Chronic Graft-Versus-Host Disease, run by Qurient Co., Ltd. at 8 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft-Versus-Host Disease
- What is being tested?
- Adrixetinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesSpain
- Study dates
- 23 Dec 2025to 31 Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
- Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia
- Recruiting
Clinica Universidad de Navarra
Pamplona
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
- Recruiting
Instituto de Investigacion Sanitaria
Valencia
About this study
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)
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).
- Conditions
- Chronic Graft-Versus-Host Disease
- Being tested
- Adrixetinib
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrixetinibDrug
Also called Q702
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Adrixetinib (Q702) | Experimental | Escalating doses of adrixetinib in 28 day cycles. Receives: Drug: Adrixetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLTs assessed for each dose level
Measured: 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.
Measured: Cycle 1 (28 Days)
Secondary outcomes (1)
Pharmacokinetics (PK)
Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites
Measured: Estimated up to Cycle 1 (28 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start23 Dec 2025
- Primary completion23 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138196
- Sponsor's protocol ID
- QRNT-012
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07138196
- Acronym / sponsor ID
- QRNT-012
- Conditions
- Chronic Graft-Versus-Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 23 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adrixetinib (Q702) | Experimental | Drug: AdrixetinibEscalating doses of adrixetinib in 28 day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdrixetinibAlso: Q702Administered orally | Drug | Adrixetinib (Q702) |
Primary outcome
Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 Days)
DLTs assessed for each dose level
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.
1 secondary outcome
Pharmacokinetics (PK)
Time frame: Estimated up to Cycle 1 (28 Days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adrixetinib in people with Chronic Graft-Versus-Host Disease, run by Qurient Co., Ltd. at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qurient Clinical Trial Information (+82-31-8060-1610, clinicaltrial_info@qurient.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.