NCT06792552

A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors

A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 414 (estimated)
• Sponsor: NextCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SIM0505 for injection	Every 21 days is one cycle. Multiple dose levels of SIM0505 will be explored in dose escalation, and determine the maximum tolerated dose.
DRUG	SIM0505 for injection	Every 21 days is one cycle. 2-3 dose levels of SIM0505 will be explored in dose optimization, and determine the recommended dose (RD) of SIM0505 and evaluate the preliminary anti-tumor activity of SIM0505

Timeline

• Start date: 2025-02-26
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2025-01-24
• Last updated: 2026-01-29

Locations

17 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study