Clinical trial • Phase I • Oncology|Respiratory

IBI3009 for Extensive-stage small cell lung cancer

Phase I trial of IBI3009 for Extensive-stage small cell lung cancer. 60 participants.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Extensive-stage small cell lung cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
19-12-2025
First CTIS Authorization Date
27-04-2026

Trial design

Phase I trial across 11 sites in Denmark, Poland, Spain.

Target Sample Size
60

Eligibility

Recruits 60 Vulnerable population selected: true; no details on consent or assent handling provided in the available data..

Vulnerable Population
Vulnerable population selected: true; no details on consent or assent handling provided in the available data.

Recruitment

Planned Sample Size
60
Recruitment Window Months
32
Consent Approach
Informed consent process not described in the available data.

Geography

Total Number Of Sites
11
Total Number Of Participants
30

Denmark

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
12
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Lise Eckhoff
Contact Person Email
ouh.ode.r.ctis@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Dept of Oncology, Phase 1 Clinic
Contact Person Name
Rikke Loevendahl Eefsen
Site Name
Rigshospitalet
Department Name
Department of Oncology
Contact Person Name
Kristoffer Staal Rohrberg

Poland

Earliest CTIS Part Ii Submission Date
15-04-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
15
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
dariusz.kowalski@nio.gov.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Piotr Wysocki
Contact Person Email
pwysocki@uck.gda.pl
Site Name
Pratia S.A.
Department Name
Pratia Poznań
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com
Site Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Contact Person Name
Aleksandra Szczęsna
Contact Person Email
ola_szczesna@outlook.com

Spain

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
61
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Amparo Sánchez Gastaldo
Contact Person Email
asanchezgastaldo@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Oscar José Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Gonzaga Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org

Sponsor

Primary sponsor

Full Name
Fortvita Biologics (USA) Inc.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
United States

Investigational products

Investigational Product Name
IBI3009
Combination Treatment
Yes

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