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

ConditionExtensive Stage Small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorChugai Pharmaceutical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

ALPS12
Drug
ALPS12 as an IV infusion
obinutuzumab
Drug
Obinutuzumab as an IV infusion

Treatment groups

122 Participants

are divided into 2 treatment groups

Group A: Dose escalation partExperimental treatment 2 interventions

Group B: Expansion partExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Secondary outcomes

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)

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.

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)