NCT06054932

Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors

A Phase I Study of LK101 Monotherapy in Participants With Advanced Solid Tumors to Evaluate the Safety, Tolerability, and Immunogenicity

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing Likang Life Science and Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labeled, single-center phase I study in patients with incurable advanced solid tumors, who failed with all previous standard therapy. The aim is to observe and evaluate the safety, tolerability, and immunogenicity of LK101 injection.

Detailed description

This study is designed to evaluate the safety, tolerability, and immunogenicity of the dose escalation of LK101. We used the traditional "3+3" dose escalation design, Subjects who have been pathologically diagnosed with advanced solid tumors and defined as failing all previous standard therapy. LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. The dose escalation will be conducted in a sequential manner, enrolled patients were initially placed in cohort 1, in which the priming phase is administered at 2-week intervals. And then followed the next cohort 2, where the priming phase is administered at 1-week intervals. Decisions with regard to dose escalation to the next dose level will be made jointly by the investigators and the sponsor. AE data was collected until the 21 days following the last prime dose. safety and immunogenicity will also be used to inform the final dose and schedule. A minimum of 6 patients will be treated at the MTD/RP2D.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LK101 injection	LK101 administrated Q2W as the prime dose, and Q3W in the boost phase
DRUG	LK101 injection	LK101 administrated QW as the prime dose, and Q3W in the boost phase

Timeline

• Start date: 2023-09-05
• Primary completion: 2025-12-30
• Completion: 2026-03-30
• First posted: 2023-09-26
• Last updated: 2023-09-26

Locations

2 sites across 1 country: China