A Study of QLS5133 Monotherapy in Advanced Solid Tumors

Launched by QILU PHARMACEUTICAL CO., LTD. · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called QLS5133 to see if it can help adults with advanced solid tumors, which are cancers that have spread and are difficult to treat. The study has two main parts: the first part will test different doses of the medicine to find out if it is safe and how the body processes it, while the second part will look more closely at how well the medicine works against the tumors. The trial is not yet open for new participants.

Adults aged 18 and older who have measurable tumors and are in generally good health (able to carry out daily activities) may be eligible to join. To qualify, participants should have recovered from side effects of previous cancer treatments and have good heart function. People who have certain health issues, like active brain cancer spread, recent serious bleeding, or a history of certain blood disorders or other cancers, may not be eligible. During the study, participants will receive QLS5133 and be closely monitored for side effects and signs that the treatment is working. This early-stage trial is mainly focused on safety, but also looks for initial signs that the medicine might help control the cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥ 18 years on the day of signing the ICF, male or female;
• • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
• • Measurable disease, per RECIST v1.1;
• • Adequate organ function;
• • Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
• • Left ventricular ejection fraction (LVEF) ≥ 50%;
• Exclusion Criteria:
• • Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
• • Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
• • Progressive or symptomatic brain metastases;
• • Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
• • History of significant cardiac disease, or poorly controlled diabetes mellitus;
• • History of recurrent autoimmune diseases;
• • History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• • History of other active malignant tumors within 3 years before signing the informed consent form;
• • If female, is pregnant or breastfeeding;
• • Be allergic to any component of QLS5133 or its excipients.