Clinical trial • Phase I • Oncology

ZL-1310 for Small cell lung cancer

Phase I trial of ZL-1310 for Small cell lung cancer. adaptive. 89 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
31-07-2024
First CTIS Authorization Date
31-10-2024

Trial design

adaptive Phase I trial across 11 sites in Spain.

Adaptive
Yes
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
89
Trial Duration For Participant
1255

Recruitment

Planned Sample Size
89
Recruitment Window Months
41

Geography

Total Number Of Sites
11
Total Number Of Participants
89

Spain

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
622
Number Of Sites
11
Number Of Participants
80

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Department
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology Department
Contact Person Name
Maria Eugenia Olmedo Garcia
Contact Person Email
maruolmedogarcia@hotmail.com
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology Department
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology Department
Contact Person Name
Valentina Gambardella
Contact Person Email
vgambardella@incliva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology Department
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology Department
Contact Person Name
Juan Jose Soto Castillo
Contact Person Email
juanj.soto@startmadrid.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology Department
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Vall D Hebron Institute Of Oncology
Department Name
Oncology Department
Contact Person Name
Pedro Filipe Simoes Da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology Department
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
ojjuanv@seom.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology Department
Contact Person Name
Alejandro Falcon Gonzalez
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology Department
Contact Person Name
David Vicente Baz

Sponsor

Primary sponsor

Full Name
Zai Lab (US) LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
ZL-1310

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