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

Phase 1

Not yet recruiting

• Conditions: Advanced Malignant Tumor
• Interventions: Drug: QLS1304 tablet

• Registration Number: NCT06823609
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-03
• Primary Completion: 2026-11
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS1304 tablet	QLS1304 tablet	-

Primary Outcome Measures

Name	Time	Method
Dose limited toxicity (DLT) of QLS1304	up to 35 days
Recommended Phase II Dose (RP2D) of QLS1304	up to 35 days
Maximum tolerated dose（MTD）of QLS1304	up to 35 days

Secondary Outcome Measures

Name	Time	Method
AUC0-inf	through study completion, an average of 2 year
MRT	through study completion, an average of 2 year
Cmax	through study completion, an average of 2 year
Tmax	through study completion, an average of 2 year
AUC0-t	through study completion, an average of 2 year
adverse event	from the first drug administration to within 30 days for the last treatment dose
objective response rate(ORR)	through study completion, assessed up to 24 months
CL/F	through study completion, an average of 2 year
Vd/F	through study completion, an average of 2 year
t1/2	through study completion, an average of 2 year