RecruitingEarly Phase 1NCT06106152

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

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

20 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new immunotherapy drug called WTX212A — either on its own or combined with a PD-1/PD-L1 checkpoint inhibitor — in people with advanced non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) that has progressed after prior treatments, including at least 2 cycles of immunotherapy. **You may be eligible if...** - You are 18–75 years old - You have confirmed advanced NSCLC (stage IIB–IV) or extensive-stage SCLC - Your disease has progressed after at least one prior line of systemic therapy, and you have received PD-1/PD-L1 immunotherapy in your most recent treatment - Your general health is good (ECOG ≤ 1) - Expected survival of at least 3 months **You may NOT be eligible if...** - You have another serious uncontrolled medical condition (uncontrolled diabetes, active bleeding, severe heart disease) - You need repeated drainage of fluid from the chest or abdomen - You have had severe lung inflammation (pneumonitis, pulmonary fibrosis) related to prior treatment - You had to permanently stop immunotherapy (IO) due to a serious side effect - You have had another cancer within the past 3 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGWTX212A injection

The WTX212A infusion is given every 21 days

DRUGPD -1/PD-L1 monoclonal antibody

The PD -1/PD-L1 monoclonal antibody is given every 21 days


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06106152


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