Chronic Graft-Versus-Host Disease
Conditions
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).
Interventions
DRUGAdrixetinib
Administered orally
Sponsors
Qurient Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 Days) | DLTs assessed for each dose level |
| Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) | Cycle 1 (28 Days) | AEs and SAEs assessed for each dose level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) | Estimated up to Cycle 1 (28 Days) | Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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 |
| Duration of Response (DOR) | 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 |
| 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) | 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. |
Countries
Spain
Contacts
Primary ContactQurient Clinical Trial Information
Outcome results
None listed