NCT05979155

A Study of NWY001 in Subjects With Advanced Solid Tumors

A Multicenter, Non-randomized, Open-label, Multiple-Dose Phase I Study of NWY001, in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts: Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part

Detailed description

Part 1: Patients with advanced solid tumors that has relapsed from or is refractory to standard therapy or for which no standard therapy exists will be enrolled in different cohorts. Part 2: Recommended Phase 2 dose (RP2D) of NWY001 will be given to all patients enrolled in this part.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	NWY001	Part 1: Participants will be given a single-dose of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.
BIOLOGICAL	NWY001	Part 2: Participants will be given RP2D of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-01-01
• Completion: 2028-05-01
• First posted: 2023-08-07
• Last updated: 2024-07-16

Locations

1 site across 1 country: China