Name: 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
Creator: Chugai Pharmaceutical
Published: 2025-08-06
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07107490 for Extensive Stage Small Cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER Phase 1 122 Open-Label

Recruiting

Clinical Trial NCT07107490 is designed to study Treatment for Extensive Stage Small Cell Lung Cancer. It is a Phase 1 interventional study that is recruiting, having started on 8 October 2025, with plans to enroll 122 participants. Led by Chugai Pharmaceutical, it is expected to complete by 30 September 2028. The latest data from ClinicalTrials.gov was last updated on 6 February 2026.

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.

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

Conditions

Extensive Stage Small Cell Lung Cancer

Other Study IDs

ALP102CT

NCT ID Number

NCT07107490

Start Date (Actual)

2025-10-08

Last Update Posted

2026-02-06

Completion Date (Estimated)

2028-09-30

Enrollment (Estimated)

122

Study Type

Interventional

PHASE

Phase 1

Status

Recruiting

Primary Purpose

Treatment

Design Allocation

Non-Randomized

Interventional Model

Sequential

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalDose escalation part 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.	ALPS12 ALPS12 as an IV infusion obinutuzumab Obinutuzumab as an IV infusion
ExperimentalExpansion part Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect.	ALPS12 ALPS12 as an IV infusion obinutuzumab Obinutuzumab as an IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR)[preliminary efficacy]	ORR assessed per RECIST v.1.1 by the investigators.	From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Disease control [preliminary efficacy]	defined as the proportion of patients who have CR, PR, or stable disease (SD) as best overall response per RECIST v.1.1 as determined by the investigator.	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]	Duration of response (DoR), defined as the time from the first occurrence of CR or PR to progression disease (PD) or death from any cause (whichever occurs first), per the investigator according to RECIST v.1.1	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]	Progression-free survival (PFS), defined as the time from administration of first study treatment to the first occurrence of disease progression or death from any cause, as determined by the investigator according to RECIST v.1.1	From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Overall survival (OS)[preliminary efficacy]	Overall survival (OS), defined as the time from administration of first study treatment to death from any cause	From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Immunogenicity of obinutuzumab	Incidence of ADAs to obinutuzumab 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)
Maximum serum concentration (Cmax) and Area under the concentration time-curve (AUC) of ALPS12 with obinutuzumab[PK profile]	Serum ALPS12 concentration and its PK parameters including Cmax and AUC etc.	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]	Incidence, nature, and severity of adverse events graded according to NCI Common Terminology CTCAE v5.0, with severity of CRS determined according to the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Criteria(In parts with obinutuzumab premedication)	From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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

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)

Chugai Pharmaceutical

Study Central Contact

Contact: Clinical trials information, only use Email, [email protected]

6 Study Locations in 3 Countries

Hong Kong

Queen Mary Hospital, Hong Kong, Hong Kong

Recruiting

Japan

Chiba

National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan

Recruiting

Ehime

Ehime University Hospital, Tōon, Ehime, 791-0295, Japan

Recruiting

Osaka

Kindai University Hospital, Sakai, Osaka, 590-0197, Japan

Recruiting

Niigata Cancer Center Hospital, Niigata, 951-8566, Japan

Recruiting

Taiwan

Show Chwan Memorial Hospital, Changhua, 500, Taiwan

Recruiting

A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER Phase 1 122 Open-Label

Inclusion Criteria

Exclusion Criteria