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

Phase 1RecruitingNCT06944444

Shenyang Sunshine Pharmaceutical Co., LTD.154 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

154

Conditions

Malignant Tumors

Interventions

SSS59DRUG

A humanized antibody targeting MUC17

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

DLTs

Dose limiting toxicity

Time frame: 21 days

Safety and tolerability

Safety and tolerability assessed by incidence and severity of adverse events

Time frame: during the intervention，Within 28 days of the last dose

MTD and RP2D

Determine the maximum tolerated dose and determine the recommended phase II dose

Time frame: through study completion, an average of 2 year