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

NCT ID: NCT06944444

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-27
• Study Completion Date: 2027-12-31

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 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).

Conditions

Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A1

Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level.

Group Type: EXPERIMENTAL

SSS59

Intervention Type: DRUG

A humanized antibody targeting MUC17

Part A2

Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level.

Group Type: EXPERIMENTAL

SSS59

Intervention Type: DRUG

A humanized antibody targeting MUC17

Part A3

Dose extension will be carried out at the selected dose level, Q3W, IV.

Group Type: EXPERIMENTAL

SSS59

Intervention Type: DRUG

A humanized antibody targeting MUC17

Part B

Indication extension will be carried out at the selected level.

Group Type: EXPERIMENTAL

SSS59

Intervention Type: DRUG

A humanized antibody targeting MUC17

Interventions

SSS59

A humanized antibody targeting MUC17

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Li, MD

Role: CONTACT

Leeqi2001@hotmail.com

86+13818207333

Facility Contacts

Wenqian Geng

Role: primary

shiyilunli@sina.com

86+021-36126254

Other Identifiers

SSS59-101

Identifier Type: -

Identifier Source: org_study_id