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Recruiting NCT06823609

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

Phase I Interventional Advanced Malignant Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLS1304 tablet.
Who it may be relevant to
Registry conditions: Advanced Malignant Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug QLS1304 tablet
    QLS1304 monotherapy dose escalation and expansion

Primary outcome measures

  • Dose limited toxicity (DLT) of QLS1304 [Time frame: up to 35 days]
  • Maximum tolerated dose（MTD）of QLS1304 [Time frame: up to 35 days]
  • Recommended Phase II Dose (RP2D) of QLS1304 [Time frame: up to 35 days]
Secondary outcome measures (10)
  • adverse event [Time frame: from the first drug administration to within 30 days for the last treatment dose]
  • Cmax [Time frame: through study completion, an average of 2 year]
  • objective response rate(ORR) [Time frame: through study completion, assessed up to 24 months]
  • Tmax [Time frame: through study completion, an average of 2 year]
  • AUC0-t [Time frame: through study completion, an average of 2 year]
  • AUC0-inf [Time frame: through study completion, an average of 2 year]
  • CL/F [Time frame: through study completion, an average of 2 year]
  • Vd/F [Time frame: through study completion, an average of 2 year]
  • MRT [Time frame: through study completion, an average of 2 year]
  • t1/2 [Time frame: through study completion, an average of 2 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Cancer Hospital — Shanghai

Identifiers

NCT: NCT06823609 · QLS1304-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗