NCT06571422

Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ47156 Monotherapy and in Combination With Other Anti-Tumor Therapies in Patients With Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	WJ47156	Monotherapy study: participate will recepit WJ47156 monotherpy with 3 dose groups; Combination therapy study: participate will recepit WJ47156 and other study drug if in the combination therapy period
DRUG	JS001+Bevacizumab	Participants in Cohort1 of combination therapy phase will receive WJ47156 plus toripalimab and bevacizumab.Toripalimab and bevacizumab are administered intravenously.
DRUG	JS207	Participants in Cohort2 of combination therapy phase will receive WJ47156 plus JS207. JS207 is administered intravenously.

Timeline

• Start date: 2024-10-23
• Primary completion: 2026-05-15
• Completion: 2027-04-30
• First posted: 2024-08-26
• Last updated: 2025-02-21

Locations

1 site across 1 country: China