JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors

Advanced Solid Tumor Clinical Trial

Official title: Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors

Status Recruiting

Clinical Trial Summary

This study is an open-label, multicenter, first-in-human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression (IHC ≥ 1+).

Clinical Trial Description

This study is an open label, multicenter, first in human, Phase I/II (dose escalation and dose expansion) study to evaluate the safety, tolerability, PK, immunogenicity and efficacy of JSKN033 in patients with advanced unresectable or metastatic solid malignant tumors that are expected to be HER2 expression.

JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.

Phase I will be a dose escalation phase - Participants will be enrolled to receive 1.1 mg/kg , 2.3 mg/kg, 4.5 mg/kg, 5.6 mg/kg or 6.7 mg/kg, once a week.

Phase II will be a dose expansion phase - After/during dose escalation, SMC will select 1-2 dose levels to expand with additional patients with gastrointestinal tumor with HER2 expression each dose level for further exploration of the efficacy and safety of JSKN033. Once treatment is discontinued, participants will be followed up every 12 weeks for any AEs and alternative anti-cancer treatment. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

• NCT number: NCT06226766
• Study type: Interventional
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: Grace Yueun Hwang
• Phone: +61 29382 5873
• Email: grace.hwang@scientiaclinicalresearch.com.au
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 18, 2024
• Completion date: October 30, 2026