Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT07292402
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
JSKN022 in Subjects With Advanced Malignant Solid Tumors
Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN022 in Subjects With Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-12
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:
The goal of this clinical trial is to learn if drug JSKN022 is safe to treat patients with advanced malignant solid tumors. It will also learn about the pharmacokinetic/ pharmacodynamic profiles and preliminary antitumor activity of drug JSKN022.
Detailed Description:
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK)/pharmacodynamic (PD) profiles, and antitumor activity of JSKN022 in patients with advanced malignant solid tumors.
Patients to be enrolled are with advanced unresectable or metastatic epithelial-derived malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), or be intolerant to standard treatment, or have no access to standard treatment.
The primary objective of the study is to evaluate the safety and tolerability of JSKN022 in patients with advanced malignant solid tumors and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of JSKN022.
Patients to be enrolled are with advanced unresectable or metastatic epithelial-derived malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), or be intolerant to standard treatment, or have no access to standard treatment.
The primary objective of the study is to evaluate the safety and tolerability of JSKN022 in patients with advanced malignant solid tumors and to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of JSKN022.
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?: