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

Launched by CHUGAI PHARMACEUTICAL · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called ALPS12 in people with extensive-stage small cell lung cancer, which means the cancer has spread widely in the body. The main goal of this early-phase study is to see if ALPS12 is safe and well-tolerated, to understand how the drug behaves in the body, and to get an early look at whether it might help shrink tumors. The study has two parts: one where doses of the drug are gradually increased to find the right amount, and another where more patients receive the drug at that dose to learn more about its effects.

People who might be eligible to join are adults (over 18) with this type of lung cancer that has come back after previous treatment. They should be fairly healthy overall and able to carry out daily activities without much trouble. Participants will need to have measurable cancer tumors and provide tumor samples for study. Some people won’t be able to join, such as those who are pregnant, have certain infections, or have had specific immune-related treatments before. While the trial is not yet recruiting, those who take part can expect careful monitoring to check their safety and how their cancer responds to ALPS12. This study is important because it helps researchers learn if ALPS12 could become a new treatment option for this hard-to-treat cancer.

Gender

ALL

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)