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

Chugai Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: ALPS12; Drug: obinutuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07107490

ALP102CT

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Dose escalation part

Experimental group

Description:

Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to determine the MTD by evaluating DLTs in patients with extensive stage small cell lung cancer.

Treatment:

Drug: obinutuzumab

Drug: ALPS12

Expansion part

Experimental group

Description:

Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.

Treatment:

Drug: obinutuzumab

Drug: ALPS12