NCT05718219

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors

A Phase I, First-in-Human, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SIM0348	Several dose levels will be evaluated for SIM0348 administered as a single agent . SIM0348 will be given via IV infusion on Day 1, Day 8, Day 15, Day 22 of each cycle (28-day or depending on study cohort and phase) until disease progression or loss of clinical benefit.
DRUG	SIM0348 + Sintilimab	Selected doses from Part 1A will be evaluated for SIM0348 when they were combined with Sintilimab (200mg once every 3 weeks).

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2023-02-08
• Last updated: 2025-08-13

Locations

1 site across 1 country: China