NCT06872580

A Study of QLS1209 in theTreatment of 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 QLS1209 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 149 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety and tolerability of QLS1209 alone in patients with eligible advanced solid tumors，determine the maximum tolerated dose (MTD) or maximum drug dose（MAD）of QLS1209, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	QLS1209	Levels of QLS1209 will be explored in dose escalation, and determine the maximum tolerated dose.
DRUG	QLS1209	Every 21 days is one cycle.1-3 dose levels of QLS1209 will be explored in dose optimization, and determine the recommended dose (RD) of QLS1209 and evaluate the preliminary anti-tumor activity of QLS1209.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-03-12
• Last updated: 2025-03-12