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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
ALPS12 as an IV infusion
Obinutuzumab as an IV infusion
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGEhime University Hospital
Tōon, Ehime, Japan
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
Objective response rate(ORR)[preliminary efficacy]
ORR assessed per RECIST v.1.1 by the investigators.
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kindai University Hospital
Sakai, Osaka, Japan
RECRUITINGNiigata Cancer Center Hospital
Niigata, Japan
RECRUITINGShow Chwan Memorial Hospital
Changhua, Taiwan
RECRUITINGDisease 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.
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]
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
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]
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
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]
Overall survival (OS), defined as the time from administration of first study treatment to death from any cause
Time frame: 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
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]
Serum ALPS12 concentration and its PK parameters including Cmax and AUC etc.
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]
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)
Time frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 42 months)