Clinical trial • Phase II • Oncology

HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST SEZ6, CONJUGATED TO (2S)-2-(2-BROMOACETAMIDO)-N-... (as listed) for Small cell lung cancer

Phase II trial of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST SEZ6, CONJUGATED TO (2S)-2-(2-BROMOACETAMIDO)-N-... (as listed) for Small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer
Trial Stage
Phase II
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
17-11-2025
First CTIS Authorization Date
18-03-2026

Trial design

Randomised, open-label, standard of care comparators listed: carboplatin (intravenous) and etoposide (intravenous); atezolizumab (intravenous) is also listed as a comparator. dose and schedule not specified in the record.-controlled, adaptive Phase II trial in Belgium, Germany, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care comparators listed: CARBOPLATIN (intravenous) and ETOPOSIDE (intravenous); ATEZOLIZUMAB (intravenous) is also listed as a comparator. Dose and schedule not specified in the record.
Adaptive
True, dose optimisation elements described: objective includes to optimize and select the recommended Phase 3 dose (RP3D) of ABBV-706 in combination with atezolizumab; no detailed escalation rules or stopping rules provided in the record.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
120

Eligibility

Recruits 120 No vulnerable population selected (isVulnerablePopulationSelected=false). Country-specific informed consent documents (L1 ICFs) are provided in multiple languages..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Country-specific informed consent documents (L1 ICFs) are provided in multiple languages.

Inclusion criteria

  • {"criterion_text":"- Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 during the screening period prior to the first dose of study treatment."}
  • {"criterion_text":"- Participants must be considered suitable to receive a platinum-based chemotherapy or atezolizumab regimen as first line treatment for ES-SCLC. Chemotherapy must contain carboplatin in combination with etoposide."}
  • {"criterion_text":"- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions."}

Exclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed mixed small cell lung cancer (SCLC)."}
  • {"criterion_text":"- Prior treatment of any kind for LS-SCLC."}
  • {"criterion_text":"- Prior systemic therapy for the treatment of first line ES-SCLC."}
  • {"criterion_text":"- Participants with known active/symptomatic central nervous system (CNS) metastases"}
  • {"criterion_text":"- Participants with a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS) based on investigator assessment per RECIST v1.1.","definition_or_measurement_approach":"Based on investigator assessment per RECIST v1.1."}

Secondary endpoints

  • {"endpoint_text":"- Overall Response (OR) as Measured by Overall Response Rate (ORR) based on investigator assessment per RECIST v1.1.","definition_or_measurement_approach":"Measured by investigator assessment per RECIST v1.1 (Overall Response Rate, ORR)."}
  • {"endpoint_text":"- Duration of Response (DoR) based on investigator assessment per RECIST v1.1.","definition_or_measurement_approach":"Measured by investigator assessment per RECIST v1.1 (Duration of Response, DoR)."}
  • {"endpoint_text":"- Disease Control (DC) based on investigator assessment per RECIST v1.1.","definition_or_measurement_approach":"Measured by investigator assessment per RECIST v1.1 (Disease Control)."}
  • {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) (no further definition provided in the record)."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
37
Consent Approach
Informed consent is via country-specific L1 subject information and informed consent forms. Documents listed include Main ICFs and addenda in multiple languages (e.g. Belgium: Dutch, French, English; Germany: German; Italy: Italian; Spain: Spanish; Poland: Polish). Optional research and pregnant partner/participant ICFs are provided where applicable. Consent is provided by the participant (no assent/minor consent procedures are described).

Geography

Total Number Of Sites
25
Total Number Of Participants
60

Belgium

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
9
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Grand Hopital De Charleroi
Department Name
Oncology and Hematology
Principal Investigator Name
Benoit Colinet
Principal Investigator Email
benoit.colinet2@ghdc.be
Contact Person Name
Benoit Colinet
Contact Person Email
benoit.colinet2@ghdc.be
Site Name
CHC MontLegia
Department Name
Oncology
Principal Investigator Name
Maryam Bourhaba
Principal Investigator Email
maryam.bourhaba@chc.be
Contact Person Name
Maryam Bourhaba
Contact Person Email
maryam.bourhaba@chc.be
Site Name
Jessa Ziekenhuis
Department Name
Pneumology
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
Az Maria Middelares Gent
Department Name
Pneumology
Principal Investigator Name
Paul Germonpre
Principal Investigator Email
paul.germonpre@mijnziekenhuis.be
Contact Person Name
Paul Germonpre

Germany

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
27
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Lungenfachklinik Immenhausen
Principal Investigator Name
Achim Rittmeyer
Principal Investigator Email
s.adomeit@lungenfachklinik-immenhausen.de
Contact Person Name
Achim Rittmeyer
Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Department of Pneumology
Principal Investigator Name
Christian Grohé
Principal Investigator Email
studien.lungenklinik@jsd.de
Contact Person Name
Christian Grohé
Contact Person Email
studien.lungenklinik@jsd.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Medizinische Klinik IV Organonkologie
Principal Investigator Name
Thomas Wehler
Principal Investigator Email
thomas.wehler@innere.med.uni-giessen.de
Contact Person Name
Thomas Wehler

Italy

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
48
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
PRECISION MEDICINE-UNIVERSITY OF CAMPANIA
Principal Investigator Name
Carminia Maria Della Corte
Principal Investigator Email
carminiamaria.dellacorte@unicampania.it
Contact Person Name
Carminia Maria Della Corte
Site Name
Istituto Oncologico Veneto
Department Name
DEPARTMENT OF CLINICAL AND EXPERIMENTAL ONCOLOGY
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC 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
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Medical Oncology
Principal Investigator Name
Giuseppe Tonini
Principal Investigator Email
g.tonini@policlinicocampus.it
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@policlinicocampus.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia medica 2
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Department of Oncology
Principal Investigator Name
Francesco Passiglia
Principal Investigator Email
francesco.passiglia@unito.it
Contact Person Name
Francesco Passiglia
Contact Person Email
francesco.passiglia@unito.it
Site Name
Alma Mater Studiorum Universita Di Bologna Sede Di (Bologna Cesena Forli Ravenna Rimini)
Department Name
Dipartimento Malattie Oncologiche ed Ematologiche
Principal Investigator Name
Andrea Ardizzoni
Principal Investigator Email
andrea.ardizzoni@aosp.bo.it
Contact Person Name
Andrea Ardizzoni
Contact Person Email
andrea.ardizzoni@aosp.bo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC 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

Spain

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
26
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Oncology Medical Department
Principal Investigator Name
Laura Mezquita Perez
Principal Investigator Email
lmezquita@clinic.cat
Contact Person Name
Laura Mezquita Perez
Contact Person Email
lmezquita@clinic.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology Department
Principal Investigator Name
Antonio Calles Blanco
Principal Investigator Email
antonio.calles@live.com
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Medical Oncology. Thoracic Tumors Unit
Principal Investigator Name
Maria del Rosario Garcia Campelo
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria del Rosario Garcia Campelo
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Maria Vanesa Gutierrez Calderon
Principal Investigator Email
vgutierrezcald@gmail.com
Contact Person Name
Maria Vanesa Gutierrez Calderon
Contact Person Email
vgutierrezcald@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Luis Gonzaga Paz-Ares Rodriguez
Principal Investigator Email
lpazaresr@seom.org
Contact Person Name
Luis Gonzaga Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Principal Investigator Name
Miguel Ángel Mosteiro Lamas
Principal Investigator Email
miguelamosteiro@iconcologia.net
Contact Person Name
Miguel Ángel Mosteiro Lamas
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology Medical Department
Principal Investigator Name
Laura Mezquita Perez
Principal Investigator Email
lmezquita@clinic.cat
Contact Person Name
Laura Mezquita Perez
Contact Person Email
lmezquita@clinic.cat

Poland

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
43
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Principal Investigator Name
Katarzyna Stencel
Principal Investigator Email
kstencel@wcpit.org
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oddzial Wieloprofilowy Zachowawczy
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
izachm@wp.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
izachm@wp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworow Pluca i Klatki Piersiowej
Principal Investigator Name
Dariusz Kowalski
Principal Investigator Email
dariusz.kowalski@nio.gov.pl
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Axio
Responsibilities
codes:10,15 (DMC),6,8
Name
WCG Clinical Inc.
Responsibilities
codes:6,8
Name
Iqvia Biotech Limited
Responsibilities
code:3

Third parties

  • {"country":"United States","full_name":"Axio","duties_or_roles":"codes:10,15 (DMC),6,8","organisation_type":"Industry"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"codes:6,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"15 (Sample Management)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"15 (Imaging Management)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"15 (ePROs),7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ABBV-706
Active Substance
HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST SEZ6, CONJUGATED TO (2S)-2-(2-BROMOACETAMIDO)-N-... (as listed)
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
1
Investigational Product Name
ATEZOLIZUMAB
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Combination Treatment
Yes

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