Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors

NCT ID: NCT06823609

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2027-12-31

Brief Summary

This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.

Conditions

Advanced Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS1304 tablet

Group Type: EXPERIMENTAL

QLS1304 tablet

Intervention Type: DRUG

QLS1304 monotherapy dose escalation and expansion

Interventions

QLS1304 tablet

QLS1304 monotherapy dose escalation and expansion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Volunteer to participate in this study, sign an informed consent form and have good compliance;
• Age ≥ 18 years old, Male or female
• ECOG score: 0-1
• Expected survival ≥ 12 weeks
• Local recurrent or metastatic advanced malignant solid tumor confirmed by histopathology or cytopathology;
• Failed to standard treatment or has no standard treatment scheme;
• Baseline presence of at least one evaluable lesion according to the RECIST v1.1;
• The functional level of important organs is basically normal, meeting the requirements of the scheme
• Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
• Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
• Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent

Exclusion Criteria

• 1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
• Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
• Subjects require long-term or high-dose use of non-steroidal drugs.
• Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
• Subjects have a known or suspected severe allergy to theinvestigational drug or any of its components Subjects have other active malignant tumors within 5 years before the first use of the investigational drug.
• Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
• Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
• Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
• Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
• Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Cancer Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jian Zhang

Role: primary

syner2000@163.com

021-34778299

Other Identifiers

QLS1304-101

Identifier Type: -

Identifier Source: org_study_id