NCT06016062

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

A Multi-center Phase I/II Trial to Evaluate the Efficacy and Safety of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	RC148 Monotherapy	RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
DRUG	RC148+docetaxel Combination Therapy	RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle； Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.
DRUG	RC148+RC48 Combination Therapy	RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle； RC48 will be administered as an IV infusion on Day 1 of each 2-week cycle.
DRUG	RC148+RC88 Combination Therapy	RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle； RC88 will be administered as an IV infusion on Day 1 of each 3-week cycle.
DRUG	RC148/Bevacizumab+RC88 Combination Therapy	RC148 injection will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle; RC88 will be administered as an IV infusion on Day 1 of each 3-week cycle; Bevacizumab will be administered as an IV infusion on Day 1 of each 3-week cycle

Timeline

• Start date: 2023-09-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-29
• Last updated: 2025-01-23

Locations

31 sites across 1 country: China