NCT05829616

A Phase I Study of QLS12004 in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Initial Antitumor Activity of QLS12004 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open, dose-escalation, and dose-expansion phase I clinical trial of QLS12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of QLS12004 in subjects with advanced solid tumors.

Detailed description

This study is a single-arm, open, dose-escalation, and dose-expansion phase I clinical trial of QLS12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of QLS12004 in subjects with advanced solid tumors.The frequency of administration and the dose to be administered in subsequent clinical studies will be determined based on a combination of preliminary data.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	QLS12004	Subjects will be treated with different dose groups of QLS12004 according to the frequency and periodicity of administration as specified in the protocol, until disease progression or unacceptable toxicity.

Timeline

• Start date: 2023-04-17
• Primary completion: 2024-05-30
• Completion: 2025-05-30
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: China