RecruitingPhase 2NCT05351788

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

A Phase Ⅱ Clinical Study of Combination Therapy of SKB264 in Patients With Advanced or Metastatic Non-small Cell Lung Cancer


Sponsor

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Enrollment

110 participants

Start Date

May 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called SKB264 (an antibody-drug combination) alone or with other therapies in people with advanced or metastatic non-small cell lung cancer (NSCLC) that has not responded to previous treatments. **You may be eligible if...** - You are between 18 and 75 years old with confirmed NSCLC - Your tumor has no EGFR or ALK mutations (cohorts 1 and 2), or has an EGFR mutation and has failed prior EGFR-targeted therapy (cohort 3) - You have at least one measurable tumor on imaging - Your organ function and performance status are within acceptable ranges - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cancer has small cell components or has spread to the brainstem or spinal cord - You have active brain metastases - You have serious heart disease, uncontrolled lung disease, or significant fluid buildup around the lungs or heart - You have active hepatitis B, hepatitis C, HIV, or tuberculosis - You are pregnant or breastfeeding - You have had an organ or stem cell transplant from a donor 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

DRUGSKB264

SKB264 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (5mg/kg)

DRUGKL-A167

KL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg Q3W)

DRUGCarboplatin

Carboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle(AUC 5)

DRUGCisplatin

Cisplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (75mg/m²)


Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, China

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NCT05351788


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