A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Official title

AN OPEN-LABEL, MULTICENTER PHASE I STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY ANTI-TUMOR ACTIVITY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Overview

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.

Interventions

• Drug ALPS12
  ALPS12 as an IV infusion
• Drug obinutuzumab
  Obinutuzumab as an IV infusion

Primary outcome measures

• All part : Adverse events of ALPS12[safety and tolerability] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability] [Time frame: From Cycle 1 Day 1 to the administration of ALPS12 on Cycle 2 Day 1 (Cycle 1 is 21 days)]
• Dose Escalation part : Immunogenicity of ALPS12 [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]

Secondary outcome measures (8)

• Objective response rate(ORR)[preliminary efficacy] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Disease control [preliminary efficacy] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Duration of response (DoR)[preliminary efficacy] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Progression-free survival (PFS)[preliminary efficacy] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Overall survival (OS)[preliminary efficacy] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Immunogenicity of obinutuzumab [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Maximum serum concentration (Cmax) and Area under the concentration time-curve (AUC) of ALPS12 with obinutuzumab[PK profile] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]
• Adverse events of obinutuzumab[safety and tolerability] [Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)]

Eligibility criteria

Inclusion criteria

• 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.
• Confirmed availability of representative archival tumor specimens or fresh tumor specimen.
• Measurable disease per RECIST v.1.1.
• Adequate hematologic and end organ function

Exclusion criteria

• 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
• Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies
• Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug.
• History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase)
• Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug
• Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug
• History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease
• Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 4 centers

• National Cancer Center Hospital East — Kashiwa
• Ehime University Hospital — Tōon
• Kindai University Hospital — Sakai
• Niigata Cancer Center Hospital — Niigata

Hong Kong · 1 center

• Queen Mary Hospital — Hong Kong

Taiwan · 1 center

• Show Chwan Memorial Hospital — Changhua

Identifiers

NCT: NCT07107490 · ALP102CT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗