RecruitingPhase 1NCT06944444

A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Enrollment

154 participants

Start Date

Apr 27, 2025

Study Type

INTERVENTIONAL

Conditions

Malignant Tumors

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria7

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.