Actively Recruiting
A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-04-29
154
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, and antitumor activity of SSS59, a humanized antibody targeting MUC17, in patients with advanced malignant tumors. This open-label phase I study is designed to understand how this drug behaves in the body and its effects on tumors in patients with advanced, recurrent, or metastatic cancers who have failed or cannot tolerate standard therapies. The study consists of four parts: Part A1 and Part A2 involve dose escalation and extension with weekly and every two weeks intravenous administration, respectively. Part A3 includes dose extension with dosing every three weeks, and Part B focuses on indication extension in certain tumor types such as advanced gastric or gastroesophageal junction adenocarcinoma expressing MUC17. Dose escalation follows specific designs, including accelerated titration and 3+3 traditional methods, across multiple dose levels to identify the maximum tolerated dose and recommended dose. Participants will undergo regular safety and tolerability assessments during treatment and up to 28 days after the last dose, with long-term follow-up for dose-limiting toxicities over 21 days and monitoring through study completion. Researchers will measure drug levels, pharmacodynamics, immunogenicity, and preliminary antitumor effects at various points. The study requires patients to have adequate organ function and an ECOG performance status of 0-1, with expected survival over three months. Total participation may last about two years for outcome evaluation.
CONDITIONS
Brief Title
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically and/or cytologically documented local advanced, recurrent, or metastatic malignancies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Expected survival longer than 3 months
- Signed informed consent form
- Adequate organ function
You will not qualify if you...
- Any adverse events greater than grade 1 from prior anti-tumor treatment except hair loss and fatigue
- Pregnant or nursing women or women/men who are ready to give birth
- Symptomatic central nervous system metastasis
- Allergy to other antibody drugs or any excipients in the study drugs
- Major surgery within 4 weeks prior to first dosing
- Participation in another clinical study unless it is observational or follow-up of an intervention study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies by dose escalation and extension phases; dosing schedules include weekly, every 2 weeks, or every 3 weeks administrations.
Participants receive SSS59 drug treatment through various dosing schedules including weekly, every two weeks, or every three weeks, depending on their assigned group.
Regular dosing visits according to assigned schedule (weekly, biweekly, or triweekly intravenous infusions)
Duration - Up to 28 days after last dose for safety monitoring; long-term follow-up up to 2 years
Participants are monitored for safety and tolerability for up to 28 days after the last dose, with additional long-term follow-up for up to 2 years to assess maximum tolerated dose and recommended phase 2 dose.
Visits for safety monitoring within 28 days post-treatment and periodic assessments during long-term follow-up
Trial Site Locations
Total: 1 location
1
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Q
Qi Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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