Status:
RECRUITING
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
Lead Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
Malignant Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 ad...
Eligibility Criteria
Inclusion
- Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>3 months.
- Signed informed consent form.
- Must have adequate organ function.
Exclusion
- Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of 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.
- Underwent major surgery within 4 weeks prior to first dosing.
- The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06944444
Start Date
April 27 2025
End Date
December 31 2027
Last Update
April 29 2025
Active Locations (1)
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1
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China