NCT06226766

JSKN033 in Patients With Advanced or Metastatic Solid Malignant Tumors

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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+).

Detailed 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	JSKN033 Injection	JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.

Timeline

• Start date: 2024-01-18
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-01-26
• Last updated: 2025-09-10

Locations

1 site across 1 country: Australia