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

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De klinische studie NCT07107490 onderzoekt behandeling bij Uitgebreid stadium kleincellige longkanker. Deze Fase 1 interventioneel-studie heeft de status rekruterend. Het doel is om 122 deelnemers te includeren vanaf 8 oktober 2025. De studie wordt geleid door Chugai Pharmaceutical en de voltooiing is gepland op 30 september 2028. Laatste update op ClinicalTrials.gov: 6 februari 2026.
Beknopte samenvatting
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.
Officiële titel

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

Aandoeningen
Uitgebreid stadium kleincellige longkanker
Andere studie-ID's
  • ALP102CT
NCT-ID
NCT07107490
Startdatum (Werkelijk)
2025-10-08
Laatste update geplaatst
2026-02-06
Verwachte einddatum
2028-09-30
Inschrijving (Geschat)
122
Studietype
Interventioneel
FASE
Fase 1
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Sequentieel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelDose 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
ExperimenteelExpansion 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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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 logoChugai Pharmaceutical
Centraal Contactpersoon
Contact: Clinical trials information, only use Email, [email protected]
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