Overview

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

Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator:
Westlake Therapeutics
Treatments:
Antibodies
Antibodies, Monoclonal
Immune Checkpoint Inhibitors
Immunoglobulins
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;