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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

December 30, 2025

Study Completion Date

December 30, 2026

Conditions
Advanced Solid Tumors
Interventions
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).

Trial Locations (1)

Unknown

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

NCT05718219 - Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors | Biotech Hunter | Biotech Hunter