NCT07480733

Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.

Detailed description

This study is a Phase II clinical trial designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of JS212 and JS213 as monotherapy and in combination therapy in patients with advanced malignant solid tumors. This study plans to conduct 5 treatment cohorts: Cohort 1: JS212 Cohort 2: JS213 Cohort 3: JS212 + JS213 Cohort 4: JS212 + JS207 Cohort 5: JS212 + Toripalimab

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	JS212 for Injection	administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	JS213 for Injection	administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	JS207 for Injection	administered by intravenous infusion on Day 1 of each 21-day cycle.
DRUG	Toripalimab	administered by intravenous infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2026-04-02
• Primary completion: 2027-11-30
• Completion: 2028-11-11
• First posted: 2026-03-18
• Last updated: 2026-03-25

Locations

1 site across 1 country: China