CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT05944224
NCT05944224Phase 2RecruitingMonitorUpdated 5mo ago · Completion was 1mo ago
Slow 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.

Shanghai Pharmaceuticals Holding Co., Ltd·interventional·Posted Jul 13, 2023·Updated Jan 13, 2026

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--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027
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