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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Expansion part | Experimental | Patients will receive ALPS12 as a single agent following pretreatment of obinutuzumab to evaluate the antitumor effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALPS12 | Drug | ALPS12 as an IV infusion |
| |
| 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) |
| 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] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials information | Contact | only use Email | clinical-trials@chugai-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co.Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong | |||
| National Cancer Center Hospital East |
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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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
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| obinutuzumab |
| Drug |
Obinutuzumab as an IV infusion |
|
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) |
| Recruiting |
| Kashiwa |
| Chiba |
| 277-8577 |
| Japan |
| Ehime University Hospital | Recruiting | Tōon | Ehime | 791-0295 | Japan |
| Kindai University Hospital | Recruiting | Sakai | Osaka | 590-0197 | Japan |
| Niigata Cancer Center Hospital | Recruiting | Niigata | 951-8566 | Japan |
| Show Chwan Memorial Hospital | Recruiting | Changhua | 500 | Taiwan |