Clinical trial NCT06106152: WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Advanced Lung Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Westlake Therapeutics
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Detailed description: The trial consist of Screening Period (30 days), Treatment Period (21\*n days), Safety Follow-up Period (90 days) and Survival follow-up.

About 20 subjects are planned to be enrolled in the study.

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;

Primary outcomes:
measure: To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer.
timeFrame: 1 year
Secondary outcomes:
measure: the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients
timeFrame: 1 year
measure: To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer
timeFrame: 1 year
measure: To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients
timeFrame: 1 year
Other outcomes:
measure: To evaluate the pharmacodynamics ( PD ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer
timeFrame: 1 year
measure: To explore and evaluate WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer before and after treatment, analysis of immune cell subpopulations
timeFrame: 1 year
measure: To explore and evaluate the changes in spleen size in patients with IO- resistant advanced lung cancer before and after treatment with WTX212A injection combined with PD -1/PD-L1 monoclonal antibody
timeFrame: 1 year
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: pingli wang, phD
role: PRINCIPAL_INVESTIGATOR
References: