NCT06220838

Study SC-101 in Subjects With Advanced Malignancies

A Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-101 in Subjects With Advanced or Metastatic Solid Tumors That Express Nectin-4

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tianjin ConjuStar Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.

Detailed description

This study is the first-in-human (FIH), multi-center, open-label trial of SC-101, including the dose escalation and expansion phases. The dose escalation study is primarily designed to assess the safety and tolerability of SC-101 and to determine the recommended dose(s) for the dose expansion study. The dose expansion study is designed with the primary objective of evaluating the clinical activity of SC-101 in patients with metastatic urothelial carcinoma or other solid tumors that express Nectin-4.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SC-101	All subjects will receive a single intravenous (IV) infusion of SC-101 once weekly.

Timeline

• Start date: 2024-02-02
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2024-01-24
• Last updated: 2025-07-29

Locations

5 sites across 1 country: China