QLS-1304 for adults with advanced malignant solid tumors — Phase 1 dose escalation and expansion

A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors

This Phase 1 study tests whether the oral drug QLS-1304 is safe, tolerable, and shows signs of benefit in adults with advanced malignant solid tumors who have exhausted standard treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT06823609 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase 1 trial uses a dose-escalation stage followed by dose-expansion cohorts to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS-1304 monotherapy in adults with locally recurrent or metastatic malignant solid tumors. Eligible participants must have histologically confirmed disease, ECOG 0–1, at least one measurable lesion by RECIST v1.1, and adequate organ function. The dose-escalation portion will identify dose-limiting toxicities and a recommended dose, while expansion cohorts will explore early anti-tumor activity and further safety signals. Female participants of childbearing potential must have a negative pregnancy test and all participants must agree to effective contraception during treatment and for 180 days after the last dose.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with histologically confirmed locally recurrent or metastatic malignant solid tumors, ECOG 0–1, adequate organ function, at least one measurable lesion, and who have progressed on or lack standard treatments.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under 12 weeks, active pregnancy or breastfeeding, uncontrolled organ dysfunction, or effective standard treatment options available are unlikely to benefit.

Why it matters

Potential benefit: If successful, QLS-1304 could offer a new oral treatment option that slows disease progression for some patients with advanced solid tumors who have no standard therapies left.

How similar studies have performed: Dose-escalation and expansion Phase 1 designs are standard for first-in-human oncology drugs; similar early-phase programs of novel anticancer agents have occasionally shown promising activity but many do not translate into later-stage success.

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.

Where this trial is running

Shanghai

• Fudan University Cancer Hospital — Shanghai, China (RECRUITING)

Conditions: Advanced Malignant Tumor