QLS5212 in people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multi-center, first-in-human trial of QLS5212. It uses dose-escalation and cohort-expansion to evaluate multiple dosing regimens in participants with unresectable locally advanced or metastatic solid tumors. The study will monitor safety, tolerability, and preliminary signals of activity, with careful assessment of laboratory tests and adverse events. Enrollment requires informed consent, adequate organ function, measurable disease, and an ECOG performance status of 0 or 1. The trial is conducted in China at Shanxi Provincial Cancer Hospital, led by Qilu Pharmaceutical Co., Ltd., and does not list collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
* Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
* Age ≥ 18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
* Life expectancy ≥ 3 months.
* Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI.

  7\. Acceptable laboratory parameters:
  1. Absolute neutrophil count ≥ 1,500/μL.
  2. Platelet count ≥ 100 × 1000/μL
  3. Hemoglobin ≥ 9.0 g/dL.
  4. Albumin ≥ 3 g/dL.
  5. ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）
  6. Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
  7. a calculated or measured creatinine clearance ≥60 mL/minute.
* Identification of an archival tumor sample (i.e., tissue block \[formalin-fixed paraffin-embedded\] or a series of approximately 10-15 slides).

Exclusion Criteria:

* History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
* Untreated or active brain metastases, including leptomeningeal carcinomatosis;
* Prior systemic anti-cancer therapy within specified windows;
* Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
* Clinically significant cardiovascular disease;
* Uncontrolled systemic infection or active tuberculosis;
* Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;
* Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.

Where it's running

• Shanxi Provincial Cancer Hospital (China Medical Sciences Academy Cancer Hospital Shanxi Hospital)
  Taiyuan, China Recruiting

Study contacts

• Study coordinator: Jie Wang, Doctor
• Email: zlhuxi@163.com
• Phone: 0351-4881611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.