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).
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.
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.
Sequential
Adrixetinib
DrugAdministered orally
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLTs assessed for each dose level
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
AEs and SAEs assessed for each dose level.
Pharmacokinetics (PK)
Maximum Observed Plasma Concentration (Cmax), area under the curve AUC of Q702 and its primary metabolites
Objective Response Rate (ORR)
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)
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)
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.
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