NCT07101549

Treating Nectin-4-positive Advanced Solid Tumors With R-Star001 (Nectin-4-CART-IL18)

A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of R-Star001 Cell Injection in Patients With Nectin-4-positive Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: changjianhua · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A single-center, single-arm, dose-escalation exploratory clinical trial on the safety, efficacy, and pharmacokinetics of R-Star001 cell injection in patients with Nectin-4-positive advanced solid tumors.

Detailed description

This study is a prospective, single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of the R-Star001 cell injection in subjects with Nectin-4 positive advanced solid tumors. The study will enroll subjects with pathologically confirmed advanced solid tumors (including, but not limited to breast cancer, urothelial carcinoma, colorectal cancer, head and neck squamous cell carcinoma, ovarian cancer, esophageal cancer, lung cancer) who have failed standard therapy; AND immunohistochemical analysis of histological or cytological tumor specimens demonstrates moderate to high Nectin-4 expression. This prospective, single-center, single-arm, open-label study employs a single-dose administration design across two sequential stages. Stage 1 (Dose Escalation) utilizes an accelerated titration approach with standard '3+3' dose escalation to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of R-Star001 Cell Injection in subjects with Nectin-4 positive advanced solid tumors, thereby determining expansion dose levels based on integrated cohort data. Stage 2 (Dose Expansion) will enroll up to 9 subjects per cohort (including escalation-phase subjects) at 1-2 selected dose levels to further characterize safety and efficacy. The Recommended Phase II Dose (RP2D) will be determined post-infusion through comprehensive analysis of Stage 1 safety/efficacy outcomes, pharmacokinetic profiles, and prior preclinical/clinical evidence. Main purpose: the safety and tolerability of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors, and determine the Recommended Phase II Dose (RP2D). Secondary Purpose: The pharmacokinetic and pharmacodynamic characteristics of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors; To preliminarily evaluate the efficacy of R-Star001 cell injection in patients with Nectin-4 positive advanced solid tumors. Evaluate the immunogenicity of R-Star001 cell injection.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	R-Star001	Drug: Nectin-4-targeted CAR T-cell injection with inducing IL-18 secretion (R-Star001). The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: China