Clinical trial NCT06823609: Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
Official title: A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Dose limited toxicity (DLT) of QLS1304
timeFrame: up to 35 days
measure: Maximum tolerated dose（MTD）of QLS1304
timeFrame: up to 35 days
measure: Recommended Phase II Dose (RP2D) of QLS1304
timeFrame: up to 35 days
Secondary outcomes:
measure: adverse event
timeFrame: from the first drug administration to within 30 days for the last treatment dose
measure: Cmax
timeFrame: through study completion, an average of 2 year
measure: objective response rate(ORR)
timeFrame: through study completion, assessed up to 24 months
measure: Tmax
timeFrame: through study completion, an average of 2 year
measure: AUC0-t
timeFrame: through study completion, an average of 2 year
measure: AUC0-inf
timeFrame: through study completion, an average of 2 year
measure: CL/F
timeFrame: through study completion, an average of 2 year
measure: Vd/F
timeFrame: through study completion, an average of 2 year
measure: MRT
timeFrame: through study completion, an average of 2 year
measure: t1/2
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
Study officials:
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