NCT06038396

A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors

A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC118 in Combination with Toripalimab / RC148 for Patients with Claudin 18.2-Positive, Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer/Gastro-esophageal junction cancer.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RC118	Dose A or dose B, Q2W
DRUG	Toripalimab	Fixed dose, Q3W
DRUG	RC148	Fixed dose, Q3W Other Names: RC148 injection

Timeline

• Start date: 2023-08-03
• Primary completion: 2026-02-28
• Completion: 2026-08-31
• First posted: 2023-09-14
• Last updated: 2025-01-29

Locations

18 sites across 1 country: China