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

NCT07107490 | Recruiting Phase 1

• 1 other identifier: ALP102CT
• Study Type: interventional
• Target: 122
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• All part : Adverse events of ALPS12[safety and tolerability]

  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

  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]

  Nature and frequency of DLTs, AEs, PK and PD profiles

  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

  Incidence of ADAs to ALPS12 and potential correlation with PK parameters and safety

  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

  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

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)

Secondary Outcomes (8)

• Objective response rate(ORR)[preliminary efficacy]

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)

• Disease control [preliminary efficacy]

  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]

  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]

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)

• Overall survival (OS)[preliminary efficacy]

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)

Study Arms (2)

Dose escalation part

EXPERIMENTAL

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.

Drug: ALPS12; Drug: obinutuzumab

Expansion part

EXPERIMENTAL

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

Drug: ALPS12; Drug: obinutuzumab

Interventions

ALPS12 DRUG

ALPS12 as an IV infusion

Dose escalation part; Expansion part

obinutuzumab DRUG

Obinutuzumab as an IV infusion

Dose escalation part; Expansion part

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (6)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Ehime University Hospital

Tōon, Ehime, 791-0295, Japan

RECRUITING

Kindai University Hospital

Sakai, Osaka, 590-0197, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

RECRUITING

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

RECRUITING

MeSH Terms

Interventions

obinutuzumab

Study Officials

• Sponsor Chugai Pharmaceutical Co.Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Central Study Contacts

Clinical trials information

CONTACT

only use Email; clinical-trials@chugai-pharm.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

TW (1); HK (1); JP (4)