A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChugai Pharmaceutical
About this trial
This study is a phase I, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of ALPS12 in patients with extensive-stage small cell lung cancer. The study consists of two parts: a dose-escalation part and an expansion part.
Eligibility criteria
Qualifiers
Aged >18 years at time of informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Histologically documented extensive stage small cell lung cancer
Disease recurrence documented after at least one prior systemic therapy.
Disqualifiers
Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study
History or complication of clinically significant autoimmune disease
a positive HIV antibody test at screening
Active hepatitis B or hepatitis C
Trial design
Treatments tested in this trial
- ALPS12
- obinutuzumab
Treatment groups
122 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov