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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
All part : Adverse events of ALPS12[safety and tolerability] — From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) Incidence, nature, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0, and CRS and Immune effector cell-associated neurotoxicity syndrome (ICANS) graded according to the ASTCT Consensus Grading Criteria
Dose Escalation part : Dose-limiting toxicities (DLTs) and PK profile of ALPS12[safety and tolerability] — From Cycle 1 Day 1 to the administration of ALPS12 on Cycle 2 Day 1 (Cycle 1 is 21 days) Nature and frequency of DLTs, AEs, PK and PD profiles
Dose Escalation part : Immunogenicity of ALPS12 — From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) Incidence of ADAs to ALPS12 and potential correlation with PK parameters and safety
Expansion part : Preliminary anti-tumor activity of ALPS12 when administered at selected dose(s) based on tumor assessment in patients with extensive stage SCLC — From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months) Objective response, defined as a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, as determined by the Investigators
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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