NCT07105215

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess the efficacy of RC278 at the RP2D dose;

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	RC278	Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-12-31
• Completion: 2030-05-31
• First posted: 2025-08-05
• Last updated: 2025-11-26

Locations

39 sites across 1 country: China