SPH4336
DrugSPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle
NCT Number: NCT05944224
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Fujian Cancer Hospital, Fuzhou, Fujian, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SPH4336 Tablets :Orally, 400mg once a day ; 28 days/cycle
Intravenous infusion, 6mg/Kg,28 days/cycle
Time frame: Approximately 2 years
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Approximately 2 years
Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
Time frame: Approximately 2 years
PK (Pharmacokinetics) parameters.
Time frame: Approximately 2 years
PK (Pharmacokinetics) parameters.
Time frame: Approximately 2 years
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
Time frame: Approximately 2 years
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.
Time frame: Approximately 8 years
Determination of the overall survival times of all patients.
Time frame: Approximately 2 years
Safety and tolerability
Contact information is provided by the study sponsor or research team.
Shanghai Pharmaceuticals Holding Co., Ltd
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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