At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 63 target
Drug / intervention
SPH4336 +1 moredrug
Likely dose
SPH4336 400mgfrom record
Key inclusion· 6
- ✓Advanced solid tumors including Well differentiated/dedifferentiated liposarcoma not amenable to radical surgery or local treatment
- ✓Expected survival ≥3 months
- ✓At least one measurable lesion per RECIST v1.1 in dose expansion phase
- ✓Prior chemotherapy toxicity recovered to ≤ grade 2 for peripheral neuropathy and ≤ grade 1 for other reversible toxicities
Key exclusion· 11
- ✕Taking anti-tumor traditional Chinese medicines at time of consent
- ✕Unrecovered adverse effects from prior surgery
- ✕History of other malignancies prior to study start
- ✕Significant cardiac disease: history of MI, unstable angina, severe arrhythmia, symptomatic CHF, NYHA ≥II, QTcF ≥470 ms, or LVEF ≤50%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05944224Phase 2RecruitingMonitorUpdated 5mo ago · Completion was 1mo agoSlow Enrollment
Monitor
A Randomized, Open-label, Phase Ib/IIa Clinical Study to Evaluate the Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors, Including Advanced Well Differentiated/Dedifferentiated Liposarcoma.
In Brief
A Phase 2 clinical trial evaluating SPH4336 and Cadonilimab for Advanced Solid Tumors. Currently recruiting, targeting 63 participants across 16 sites.
Signals
Enrolling slower than its timeline implies
Detailed Summary
This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
2024202520262027
First PostedJul 2023
Enrollment StartOct 2023
Primary CompletionMay 2026
TodayJul 2026
Study CompletionDec 2026
First PostedJul 13, 2023
Enrollment StartOct 17, 2023
Primary CompletionMay 31, 2026
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 3.0 years ago
Interventions
SPH4336drug
SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle
Cadonilimabdrug
Intravenous infusion, 6mg/Kg,28 days/cycle