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TQ05105 + TQB3909 in myelofibrosis
NCT06245941Phase 2
Key facts
- Status
- Terminated
- Start
- May 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- TQB3909
- Conditions
- myelofibrosis (MF)
01
Overview
Phase 2, open-label trial of TQB3909 in myelofibrosis (MF) (2 arms), sponsored by Chia Tai-Tianqing Pharmaceutical Group. Primary endpoints: Maximal Tolerance Dose at 2 years, Recommended Phase II Dose at 2 years and 1 more. Started May 2024; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
TQB3909 Monotherapy
TQB3909 tablets orally administered in 28-day cycles
TQ05105 + TQB3909 Combination
TQ05105 tablets combined with TQB3909 tablets orally administered in 28-day cycles
03
Who it enrols
Adults ≥18 years with moderate- or high-risk primary myelofibrosis, post-PV-MF, or post-ET-MF per DIPSS or NCCN criteria, with splenomegaly and ≤10% blasts. Includes patients with prior JAK inhibitor failure or JAK-naive patients. Excludes prior allogeneic transplant, BCL-2/JAK combination therapy, splenectomy, active infections, hepatitis B/C, HIV, and other malignancies within 3 years.
04
Endpoints
Primary
Maximal Tolerance Dose
Recommended Phase II Dose
35% Reduction in Spleen Volume at Week 24
Secondary
Optimum Effective Rate
Onset Time of Splenic Response
Duration of Maintenance of at Least 35% Reduction in Spleen Volume
Percentage Change in Spleen Volume from Baseline
35% Reduction in Spleen Volume at Week 60
Myeloproliferative Neoplasm - Symptom Assessment Form - Total Symptom Score
MPN-SAF-TSS Decrease
Progression-Free Survival
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