SPH6516 tablets
DrugSPH6516 tablets : Orally, once daily, 25-200mg, 28 days a cycle
NCT Number: NCT06266923
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.
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Notify Me18 year–70 year
All sexes
Interventional
Early Phase 1
Sun Yat-sen University Cancer Center, Guangzhou, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SPH6516 tablets : Orally, once daily, 25-200mg, 28 days a cycle
Time frame: Approximately 2 years
Maximum tolerated dose
Time frame: Approximately 2 years
Adverse event type, incidence, duration
Time frame: Approximately 2 years
PK (Pharmacokinetics)
Time frame: Approximately 2 years
PK (Pharmacokinetics)
Time frame: Approximately 2 years
PK (Pharmacokinetics)
Time frame: Approximately 2 years
PK (Pharmacokinetics)
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
The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.
Shanghai Pharmaceuticals Holding Co., Ltd
Industry
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of SPH6516 Tablets in Subjects With Advanced Solid Tumors.
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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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