Next-Generation Targeted Therapy QLS5133 Enters Clinical Trials, Now Recruiting Patients with Advanced Solid Tumors

Sep 17, 2025 23:59 CST Updated 23:59

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

QLS5133 is an antibody-drug conjugate (ADC) targeting CDH6, developed based on Qilu Pharmaceutical's proprietary novel topoisomerase 1 (TOPO 1) inhibitor platform and obtained through site-specific conjugation technology with a DAR value of 8. Its payload, QLS6916, demonstrates nanomolar-level activity in various cancer cell lines.

Now, this new anti-cancer drug has finally officially launched clinical trials! Patients in China can now access it throughGlobal Cancer Doctors Network Medical Department (4006667998), understand the detailed inclusion and exclusion criteria, or preliminarily assess whether you qualify for participation.

Introduction to Anti-Cancer Projects

Drug Name:IQLS5133；

Staging:Phase Ⅰ,Phase Ⅱ；

Line of Treatment:Standard Treatment FailureDefeat;

Mutant Gene:No Target Requirement。

Which patients are suitable?

ApplicableInFor cases where standard treatment has failed or no standard treatment is available, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and renal cell carcinoma are the preferred recommendations.。

Inclusion Criteria (Partial)

RecipientTesters RequiredMustSymbolMeet all the following criteria to be included in this study:

1) The subject voluntarily signs the Informed Consent Form (ICF) and is able to understand and comply with the requirements of the study;

2）The age on the day of signing the ICF is ≥18 years old, regardless of gender;

3）Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1;

4）Expected survival period ≥ 3 months;

5）Dose Escalation and PK Expansion Phase: Subjects with histologically or cytologically confirmed advanced malignant solid tumors, who have
Standard treatment failure or no standard treatment available, priority recommendation for ovarian cancer, fallopian tube cancer, primary peritoneal cancer
And renal cancer.

Exclusion Criteria (Partial)

AffectedTestPatientStill need to be scheduledExceptThe following discomfortMeet all the criteria for participation in this clinical study to be enrolled:

1. Have previously received CDH6-targeted drugs or any drug containing a topoisomerase I inhibitor.

2）Before the first use of the trial drug:

① Have received oral fluorouracil drugs, small molecule targeted drugs, palliative radiotherapy within 2 weeks or
Traditional Chinese Medicine Treatment for Antitumor Indications;

② Treated with mitomycin or nitrosourea drugs within 6 weeks;

③Received cell-based therapy or anti-tumor vaccine within 8 weeks;

④ Chemotherapy, biological therapy, endocrine therapy, immunotherapy, or monoclonal antibody therapy not mentioned above received within 4 weeks.
Monoclonal antibodies and other anti-tumor treatments, etc.

3) Subjects with moderate to large amounts of uncontrollable pleural effusion, pericardial effusion, or ascites prior to the first dose
Patients (who have been stabilized for at least 2 weeks after drainage can be enrolled).

Project Implementation Region

The study is currentlyTo be launched in areas such as Shanghai. Specific details will be confirmed upon later consultation.

Summary of Required Documents to be Submitted

The materials that patients need to prepare and submit include:Pathology Report, Genetic Testing Report, Admission Record, Discharge Summary, CT/MRI Examination, Complete Blood Count, Liver and Kidney Function, Coagulation Function, Infectious Disease Screening, Electrocardiogram Reportetc.

Global Oncology Department Warm Reminder

If you want to participate in this clinical study, or want to knowQLS5133 For more information, please contactGlobal Oncology Doctors Network Medical Department (400-666-7998), obtain more information about applications both in China and abroad, or apply directly. We promise to keep all participants' personal information confidential and ensure compliance with national laws and regulations related to clinical research throughout the entire process.

#Ark Gene Treasure Plan#

"Ark Gene Treasure Plan" is a gene "treasure hunt" initiative launched by Global Cancer Doctors Network in collaboration with Cancer-Free Home, authoritative gene testing institutions, international pharmaceutical companies, and well-known cancer centers. This program aims to thoroughly explore the survival hopes indicated in each gene testing report, comprehensively interpret the gene testing reports for cancer patients, and match cancer patients with suitable newly approved drugs and ongoing clinical trials of investigational drugs on a global scale, seeking new survival opportunities and chances for free treatment with approved or unapproved new drugs for the patients!

Patients who wish to participate can send their genetic test reports and diagnostic reports electronically.Subsidiary or PhotographyPhotoSend to: doctor.huang@globecancer.com, leave contact information in the email. The Medical Department will contact you by phone within 1 working day after receiving and analyzing the report; or call directly.Global Oncologist Network Medical Department (400-666-7998)Evaluation.

This article is original from Global Oncologist Network. Reproduction is strictly prohibited without authorization.

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