WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called WTX212A for patients with advanced lung cancer. The study aims to understand how well WTX212A works on its own and when used with another type of treatment known as PD-1/PD-L1 monoclonal antibodies. It's designed for adults aged 18 to 75 who have been diagnosed with advanced non-small cell lung cancer or extensive small cell lung cancer and have not responded well to previous treatments. Participants will need to sign a consent form, show they understand the study, and will be expected to complete all necessary procedures.

To join the trial, participants should have had at least one prior treatment for their cancer and must have a good overall health status, meaning they can carry out daily activities with minimal issues. They should also be expected to live for at least three more months. Participants will be closely monitored for safety and effectiveness throughout the study. It's important to note that individuals with certain serious health conditions, recent surgeries, or other cancers may not be eligible to participate. This trial is currently recruiting, so interested patients should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
• • Regardless of gender, aged 18 to 75 years old (including threshold);
• • Histologically or cytologically confirmed locally advanced (stage IIB/IIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) with disease progression or intolerance after treatment or extensive stage small cell Lung cancer (SCLC)
• • Patients with lung cancer who have been treated with at least 1 line system therapy or cannot currently receive standard therapy, and who have been treated with PD-1 or PD-L1 inhibitor antibody in the terminal line therapy regimen for ≥ 2 cycles;
• • ECOG ≤1
• • Expected life ≥ 3 months；
• • Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration;
• Exclusion Criteria:
• • People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
• • Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
• • Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
• • There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
• • Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. Exceptions include early tumors that have received radical treatment (carcinoma in situ or grade 1 tumor, non ulcerative primary melanoma with a depth of less than 1mm and no lymph nodes involved), skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment;
• • Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
• • Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases;
• • Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;