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SPH4336 Monotherapy or in Combination With Cadonilimab in Advanced Solid Tumors
NCT05944224Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2023
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- SPH4336
- Conditions
- solid tumorLiposarcoma
01
Overview
Phase 2, randomised, open-label trial of SPH4336 in solid tumor and Liposarcoma (3 arms), sponsored by Shanghai Pharmaceuticals Holding Co Ltd. Primary endpoint: Progression-free survival at 2 years. Started Oct 2023; status: recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
SPH4336
SPH4336 Tablets: Orally, 400mg once a day; 28 days/cycle
Cadonilimab
Intravenous infusion, 6mg/Kg, 28 days/cycle
SPH4336+ Cadonilimab
SPH4336 Tablets: Orally, 400mg once a day + Cadonilimab Intravenous infusion, 6mg/Kg; 28 days/cycle
03
Who it enrols
Patients with advanced solid tumors (including liposarcoma) who cannot be treated by radical surgery/other local treatment, with expected survival >= 3 months, adequate organ function, and recovered from prior toxicities. Excludes patients with severe cardiovascular disease, active infections (HBV, HCV, HIV, TB), or history of other malignancies.
04
Endpoints
Primary
Progression-free survival
Secondary
Objective response rate
Progression-free rate
Maximum plasma concentration
Time to maximum plasma concentration
Disease control rate
Duration of remission
Overall Survival
Incidence of Adverse event
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