Overview
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Description
This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.
Eligibility
Inclusion Criteria:
- Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks as assessed by the investigator.
- Adequate organ and bone marrow function.
- Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.
Exclusion Criteria:
- Participants with other malignant tumors within 3 years before the first dose of study treatment.
- Active or untreated central nervous system (CNS) metastasis.
- Current uncontrolled concomitant diseases
- Clinically severe lung damage due to complications of lung disorder
- Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
- A history of severe skin diseases
- Unresolved toxicity from prior anti-tumor therapy
- Serious infection within 4 weeks before the first dose of study treatment
- Known active pulmonary tuberculosis.
- Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- Pregnant or breastfeeding women.
- Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
