Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT06944444
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, China
Location status: Recruiting
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A humanized antibody targeting MUC17
Time frame: 21 days
Dose limiting toxicity
Time frame: during the intervention,Within 28 days of the last dose
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: through study completion, an average of 2 year
Determine the maximum tolerated dose and determine the recommended phase II dose
Time frame: baseline, during the intervention and at the end of the study
Maximum concentration
Time frame: baseline, during the intervention and at the end of the study
Time to peak drug concentration
Time frame: baseline, during the intervention and at the end of the study
the area under the curve (AUC) up to the last measurable concentration
Time frame: baseline, during the intervention and at the end of the study
Receptor Occupancy
Time frame: baseline, during the intervention and at the end of the study
change of cytokine
Time frame: baseline, during the intervention and at the end of the study
ADA,NAB(if ADA is positive)
Time frame: baseline, during the intervention and at the end of the study
Assessed according to Recist V1.1
Contact information is provided by the study sponsor or research team.
Shenyang Sunshine Pharmaceutical Co., LTD.
Industry
A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
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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