WTX212A treatment for advanced lung cancer

A Single-center, Open Label, Exploratory Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of WTX212A Injection Combined With PD -1/PD-L1 Monoclonal Antibody in Patients With Advanced Lung Cancer

This study is testing a new injection called WTX212A to see if it helps people with advanced lung cancer when used alone or with other treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06106152 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of WTX212A injection, both alone and in combination with PD-1/PD-L1 monoclonal antibodies, in patients with advanced lung cancer. The study is designed as a single-center, open-label trial and includes a screening period, treatment period, safety follow-up, and survival follow-up. Approximately 20 subjects will be enrolled to assess the pharmacokinetics and pharmacodynamics of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced non-small cell lung cancer or extensive stage small cell lung cancer who have progressed after prior therapies.

Not a fit: Patients with early-stage lung cancer or those who have not received prior systemic therapy 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 lung cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

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;

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: pingli wang, phD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: pingli wang, phD

Conditions Advanced Lung Cancer