SKB500 Combinations in Patients With Small Cell Lung Cancer
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with 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 criteria
Qualifiers
Male or female participants between 18 and 75 years old.
Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
Cohort 2~3: participant has received no prior systemic treatment.
Agree to provide fresh or archival tumor tissue for biomarker analysis.
Disqualifiers
The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
Has previously received medications with the same target or the same toxins.
Presence of spinal cord compression or clinically active central nervous system metastases.
Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
Trial design
Treatments tested in this trial
- SKB500 Powder for Injection
- KL-A167 Injection
- Carboplatin Injection
- Etoposide Injection
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov