Testing QLS1103 in patients with advanced solid tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors

This study is testing a new drug called QLS1103 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05884801 on ClinicalTrials.gov

What this trial studies

This phase I study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in patients with advanced solid tumors. It involves a dose escalation and dose expansion approach to determine the optimal dosage and assess how the drug interacts with the body. Participants will be closely monitored for any adverse effects and overall response to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically or cytologically confirmed advanced or recurrent solid tumors who have failed standard treatments.

Not a fit: Patients who have received systemic anticancer therapy or experimental treatments within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: While this is a phase I study, similar approaches in early-phase trials have shown promise in evaluating new cancer therapies.

Eligibility criteria

Inclusion Criteria:

* 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
* 2. Aged ≥18 years old;
* 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
* 4. Failure of adequate standard treatment, or no effective standard treatment;
* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
* 6. Life expectancy ≥12 weeks;

Exclusion Criteria:

* 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
* 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
* 3. Subjects received major surgery within 4 weeks prior to the first dose;
* 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy;
* 5. Cardiovascular and cerebrovascular diseases with clinical significance;
* 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Yilong Wu, MD — Guangdong Provincial People's Hospital
• Study coordinator: Qing Shao

Conditions: Advanced Solid Tumor