Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:39 PM
Study NCT ID:
NCT07480733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors
Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Cohort 1: JS212 Cohort 2: JS213 Cohort 3: JS212 + JS213 Cohort 4: JS212 + JS207 Cohort 5: JS212 + Toripalimab
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: