Clinical trial • Phase III • Oncology

Humanised IgG1 monoclonal antibody against CD152 for Metastatic non-small cell lung cancer

Phase III trial of Humanised IgG1 monoclonal antibody against CD152 for Metastatic non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
26-07-2024
First CTIS Authorization Date
23-10-2024

Trial design

Randomised, open-label, arm 1: onc-392 6 mg/kg q3w with two loading doses of 10 mg/kg q3w; arm 2 (comparator): docetaxel 75 mg/m2 q3w-controlled Phase III trial across 32 sites in Netherlands, Belgium, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm 1: ONC-392 6 mg/kg Q3W with two loading doses of 10 mg/kg Q3W; Arm 2 (comparator): Docetaxel 75 mg/m2 Q3W
Target Sample Size
542

Eligibility

Recruits 542 Vulnerable populations not selected. Study population limited to adults (≥18 years) who are "capable of signing informed consent"; consent must be provided by the participant themselves. No assent/guardian consent procedures are indicated in the available record..

Vulnerable Population
Vulnerable populations not selected. Study population limited to adults (≥18 years) who are "capable of signing informed consent"; consent must be provided by the participant themselves. No assent/guardian consent procedures are indicated in the available record.

Inclusion criteria

  • {"criterion_text":"- Adult (≥ 18 years), all genders, capable of signing informed consent\n- Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs\n- Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b: a. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy; b. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy. Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed\n- At least one measurable tumor lesion according to RECIST 1.1\n- ECOG score of 0 or 1\n- Adequate organ functions. Serum LDH level ≤ 2xULN\n- Life expectancy ≥ 3 months"}

Exclusion criteria

  • {"criterion_text":"- Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy\n- Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment\n- Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7 days prior to the first dose of study treatment.\n- Having non-squamous histology type or documented targetable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK. Exception: KRAS mutations are not excluded\n- Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug\n- Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease\n- Active interstitial lung disease (ILD) or noninfectious pneumonitis\n- Uncontrolled fungal or viral infection. Active infections with IV antibiotics within 14 days prior to first dose of study treatment\n- Impaired heart function"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Measured as overall survival (OS)"}

Secondary endpoints

  • {"endpoint_text":"- Objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1","definition_or_measurement_approach":"ORR assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1"}
  • {"endpoint_text":"- Progression-free survival (PFS) as assessed by BICR per RECIST 1.1","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1"}
  • {"endpoint_text":"- Incidence of TEAEs, TRAEs, irAEs, and AEs leading to treatment discontinuation.","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAE), immune-related AEs (irAEs) and AEs leading to treatment discontinuation as reported in safety assessments"}

Recruitment

Planned Sample Size
542
Recruitment Window Months
37
Consent Approach
Informed consent to be provided by the participant themselves; study limited to adults (≥18) who are "capable of signing informed consent". Subject information and informed consent form documents exist (multiple L1_SIS and ICF documents) and patient-facing materials are available in multiple languages (English, German, French, Dutch, Spanish, Italian and Belgian language variants) as indicated by the available document list.

Geography

Total Number Of Sites
32
Total Number Of Participants
100

Netherlands

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Pulmonology
Principal Investigator Name
Jeroen Kloover
Principal Investigator Email
info@etz.nl
Contact Person Name
Jeroen Kloover
Contact Person Email
info@etz.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Pulmonology
Principal Investigator Name
Wilhelmina S.M.E. Theelen
Principal Investigator Email
communicatie@nki.nl
Contact Person Name
Wilhelmina S.M.E. Theelen
Contact Person Email
communicatie@nki.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Pulmonology
Principal Investigator Name
Niels J.M. Claessens
Principal Investigator Email
online@rijnstate.nl
Contact Person Name
Niels J.M. Claessens
Contact Person Email
online@rijnstate.nl

Belgium

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
7
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Jessa Ziekenhuis
Department Name
Pulmonology
Principal Investigator Name
Kristof Cuppens
Principal Investigator Email
kristof.cuppens@jessazh.be
Contact Person Name
Kristof Cuppens
Contact Person Email
kristof.cuppens@jessazh.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Pulmonology
Principal Investigator Name
Frédérique Bustin
Principal Investigator Email
frederique.bustin@citadelle.be
Contact Person Name
Frédérique Bustin
Contact Person Email
frederique.bustin@citadelle.be
Site Name
Az Maria Middelares Gent
Department Name
Pulmonology
Principal Investigator Name
Paul Germonpré
Principal Investigator Email
paul.germonpre@mijnziekenhuis.be
Contact Person Name
Paul Germonpré
Site Name
Vitaz
Department Name
Pulmonology
Principal Investigator Name
Koenraad Deschepper
Principal Investigator Email
koen.deschepper@vitaz.be
Contact Person Name
Koenraad Deschepper
Contact Person Email
koen.deschepper@vitaz.be

Spain

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
23-10-2024
Processing Time Days
41
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Medical Oncology Department
Principal Investigator Name
Manuel Cobo Dols
Principal Investigator Email
estudios.clinicos@ibima.eu
Contact Person Name
Manuel Cobo Dols
Contact Person Email
estudios.clinicos@ibima.eu
Site Name
Hospital General Universitario De Valencia
Department Name
Medical Oncology Department
Principal Investigator Name
Paula Espinosa Olarte
Principal Investigator Email
paula.espinosa.olarte@gmail.com
Contact Person Name
Paula Espinosa Olarte
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Medical Oncology
Principal Investigator Name
Sergio Sandiego Contreras
Principal Investigator Email
SSANDIEGO@FIVO.ORG
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
SSANDIEGO@FIVO.ORG
Site Name
Hospital Universitario Lucus Augusti
Department Name
Medical Oncology Department
Principal Investigator Name
Sergio Vázquez Estévez
Principal Investigator Email
sergio.vazquez.estevez@sergas.es
Contact Person Name
Sergio Vázquez Estévez
Site Name
Hospital General Universitario De Elche
Department Name
Medical Oncology Service
Principal Investigator Name
Javier David Benitez Fuentes
Principal Investigator Email
javierdavidbenitezfuentes@gmail.com
Contact Person Name
Javier David Benitez Fuentes
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology Department
Principal Investigator Name
Antonio Calles Blanco
Principal Investigator Email
investigaoncomedica.hgugm@salud.madrid.org
Contact Person Name
Antonio Calles Blanco

Italy

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
25-10-2024
Processing Time Days
79
Number Of Sites
11
Number Of Participants
25

Sites

Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica per Patologia Toracica
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Oncologia Medica
Principal Investigator Name
Alessandra Bulotta
Principal Investigator Email
bulotta.alessandra@hsr.it
Contact Person Name
Alessandra Bulotta
Contact Person Email
bulotta.alessandra@hsr.it
Site Name
Humanitas Istituto Clinico Catanese S.p.A.
Department Name
Medical Oncology Department
Principal Investigator Name
Alessandro Russo
Principal Investigator Email
alessandro.russo@humanitascatania.it
Contact Person Name
Alessandro Russo
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SS Oncologia Medica Toraco Polmonare
Principal Investigator Name
Giuseppe Lo Russo
Principal Investigator Email
giuseppe.lorusso@institutotumori.mi.it
Contact Person Name
Giuseppe Lo Russo
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
UOC Oncologia Medica
Principal Investigator Name
Alessio Cortellini
Principal Investigator Email
a.cortellini@policlinocampus.it
Contact Person Name
Alessio Cortellini
Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Oncologia
Principal Investigator Name
Anna Cecilia Bettini
Principal Investigator Email
abettini@asst-pg23.it
Contact Person Name
Anna Cecilia Bettini
Contact Person Email
abettini@asst-pg23.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
UOC Oncologia Medica
Principal Investigator Name
Valerio Gristina
Principal Investigator Email
valerio.gristina@unipa.it
Contact Person Name
Valerio Gristina
Contact Person Email
valerio.gristina@unipa.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Oncologia Medica
Principal Investigator Name
Diego Luigi Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Luigi Cortinovis
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Medicina e Chirurgia Clinica
Principal Investigator Name
Alberto Servetto
Principal Investigator Email
alberto.servetto@unina.it
Contact Person Name
Alberto Servetto
Contact Person Email
alberto.servetto@unina.it
Site Name
Azienda Sanitaria Territoriale Di Pesaro E Urbino
Department Name
UOC Oncologia, OncoEmatologia
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@ospedalimarchenord.it
Contact Person Name
Rita Chiari
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medicina Interna, SOD Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi

Germany

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
39
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Asklepios Fachkliniken Muenchen Gauting
Department Name
Thoracic Oncology
Principal Investigator Name
Niels Reinmuth
Principal Investigator Email
n.reinmuth@asklepios.com
Contact Person Name
Niels Reinmuth
Contact Person Email
n.reinmuth@asklepios.com
Site Name
KEM I Evang. Kliniken Essen-Mitte gGmbH
Department Name
Oncology/Hematology
Principal Investigator Name
Sebastian Ertl
Principal Investigator Email
s.ertl@kem-med.com
Contact Person Name
Sebastian Ertl
Contact Person Email
s.ertl@kem-med.com
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinik für Pneumologie, Thoraxonkologie, Schlaf- und Beatmungsmedizin
Principal Investigator Name
Christian Schumann
Contact Person Name
Christian Schumann
Site Name
Klinikum Esslingen GmbH
Department Name
Cardiology, Angiology, Pneumology
Principal Investigator Name
Martin Fähling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Fähling
Site Name
Lungenfachklinik Immenhausen
Department Name
Lungenfachklinik Immenhausen Zentrum für Pneumologie
Principal Investigator Name
Achim Rittmeyer
Principal Investigator Email
arittmeyer@lungenfachklinik-immenhausen.de
Contact Person Name
Achim Rittmeyer
Site Name
Muenchen Klinik gGmbH
Department Name
Pneumologie und Pneumologische Onkologie
Principal Investigator Name
Konrad Kokowski
Principal Investigator Email
konrad.kokowski@klinikum-muenchen.de
Contact Person Name
Konrad Kokowski
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institute of Clinical Cancer Research
Principal Investigator Name
Timorshah Habibzada
Principal Investigator Email
habibzada.timorshah@khnw.de
Contact Person Name
Timorshah Habibzada
Contact Person Email
habibzada.timorshah@khnw.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Studienzentrum Thoraxonkologie
Principal Investigator Name
Farastuk Bozorgmehr
Principal Investigator Email
farastuk.bozorgmehr@med.uni-heidelberg.de
Contact Person Name
Farastuk Bozorgmehr

Sponsor

Primary sponsor

Full Name
Oncoc4 Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Biotech Limited
Name
Pharmaceutical Product Development LLC
Responsibilities
Central Labs
Name
PPD International Holdings LLC
Responsibilities
Central Labs
Name
Almac Clinical Services Limited
Responsibilities
MIA , QP
Name
Bioclinica Inc.
Responsibilities
Central Imaging Reads

Third parties

  • {"country":"China","full_name":"Wuxi Biologics (Shanghai) Co. Ltd.","duties_or_roles":"MCB and WCB testing","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"MIA , QP","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Joinn Laboratories(China)Co. Ltd.","duties_or_roles":"GLP 28-day toxicity study","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Wuxi Biologics Biosafety Testing (Suzhou) Co. Ltd.","duties_or_roles":"Establishment and storage of MCB and WCB","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging Reads","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac","duties_or_roles":"Packaging, labelling and storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Central Labs","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Wuxi Biologics Co. Ltd.","duties_or_roles":"MCB and WCB testing and storage. Drug Substance and Product Manufacture, Packaging, Release testing, Stability testing, Storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Central Labs","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"GLP 3 month toxicity studies","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ONC-392
Active Substance
Humanised IgG1 monoclonal antibody against CD152
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Investigational (prodAuthStatus 1)
Starting Dose
6 mg/kg (with two loading doses of 10 mg/kg Q3W)
Dose Levels
10 mg/kg; 6 mg/kg
Frequency
Q3W (every 3 weeks)
Maximum Dose
170 mg/kg
Investigational Product Name
Docetaxel
Active Substance
Docetaxel
Modality
Small molecule
Routes Of Administration
Intravenous infusion (concentrate for solution for infusion)
Route
Intravenous infusion
Authorisation Status
Authorized (prodAuthStatus 2)
Starting Dose
75 mg/m2 Q3W
Dose Levels
75 mg/m2
Frequency
Q3W (every 3 weeks)
Maximum Dose
1275 mg/m2

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