Extensive Stage Small Cell Lung CancerPhase 1NCT07107490
A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
A Phase 1 study testing ALPS12 and obinutuzumab in people with Extensive Stage Small Cell Lung Cancer, run by Chugai Pharmaceutical at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- ALPS12 and obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 8 Oct 2025to 30 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Japan4 sites, 4 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Niigata Cancer Center Hospital
Niigata, 951-8566
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
- Recruiting
Ehime University Hospital
Tōon, Ehime, 791-0295
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua, 500
About this study
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
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
- Being tested
- ALPS12, obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPS12Drug
ALPS12 as an IV infusion
obinutuzumabDrug
Obinutuzumab as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ALPS12; Drug: obinutuzumab |
| Expansion part | Experimental | Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect. Receives: Drug: ALPS12; Drug: obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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]
ORR assessed per RECIST v.1.1 by the investigators.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start8 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co.Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107490
- Sponsor's protocol ID
- ALP102CT
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07107490
- Acronym / sponsor ID
- ALP102CT
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation part | Experimental | Drug: ALPS12, Drug: obinutuzumabPatients 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. |
| Expansion part | Experimental | Drug: ALPS12, Drug: obinutuzumabPatients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPS12ALPS12 as an IV infusion | Drug | Dose escalation part, Expansion part |
| obinutuzumabObinutuzumab as an IV infusion | Drug | Dose escalation part, Expansion part |
Primary outcome
All part : Adverse events of ALPS12[safety and tolerability]
Time frame: 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]
Time frame: 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
Time frame: 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
Time frame: 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
8 secondary outcomes
Objective response rate(ORR)[preliminary efficacy]
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Disease control [preliminary efficacy]
Time frame: 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]
Time frame: 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]
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Overall survival (OS)[preliminary efficacy]
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Immunogenicity of obinutuzumab
Time frame: 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]
Time frame: 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]
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sponsor Chugai Pharmaceutical Co.Ltd study director
clinical-trials@chugai-pharm.co.jp
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALPS12 and obinutuzumab in people with Extensive Stage Small Cell Lung Cancer, run by Chugai Pharmaceutical at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical trials information (only use Email, clinical-trials@chugai-pharm.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All part : Adverse events of ALPS12[safety and tolerability] (time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.