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

Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: Advanced Lung Cancer

Treatments: Drug: PD -1/PD-L1 monoclonal antibody; Drug: WTX212A injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06106152

Reboot-105

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Fixed-dose in patients with advanced lung cancer

Experimental group

Description:

WTX212A injection Fixed-dose in advanced lung cancer patients

Treatment:

Drug: WTX212A injection

Combined Study in patients with advanced lung cancer

Experimental group

Description:

Fixed-dose WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Treatment:

Drug: WTX212A injection

Drug: PD -1/PD-L1 monoclonal antibody