This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.
Voluntary and signed informed consent, good compliance.
Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted.
Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
Prior splenectomy or splenic radiotherapy within 6 months before first dose.
Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
Single group
TQ05105 Tablets (Rovadicitinib Tablets)
DrugTQ05105 is an inhibitor of Janus kinase 1 (JAK1), Janus kinase 2 (JAK2), and Rho-associated coiled-coil containing protein kinase 1 (ROCK1) and 2 (ROCK2).
Proportion of subjects with ≥35% reduction in spleen volume from baseline at week 24 (SVR35)
SVR35 at week 24 as assessed by Independent Review Committee (IRC)
Peak concentration (Cmax)
Maximum plasma concentration of TQ05105 and its metabolite(s).
Time to peak concentration (Tmax)
Time to reach maximum plasma concentration of TQ05105 and its metabolite(s).
Elimination half-life (t1/2)
Half-life of TQ05105 and its metabolite(s) in plasma.
Best response rate of spleen volume reduction
Proportion of subjects with at least one occurrence of ≥35% reduction in spleen volume from baseline.
Onset time of splenic response
The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from the baseline.
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
Duration of spleen volume reduction ≥ 35% from baseline: the time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction \< 35% from baseline.
Percentage change in spleen volume from baseline at planned visits
Percentage change in spleen volume relative to baseline at each planned visit.
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