A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti_Tumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients with Advanced Solid Tumors.

Status Authorised, recruitment pending · 5 EU/EEA countries · 32 sites · Protocol AVZO-021-1001

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans

Status Authorised, recruitment pending

Participants planned 354

Countries 5

Sites 32

Advanced Solid Tumors

Key facts

Sponsor: Avenzo Therapeutics Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2025-03-10
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-517339-30-00
ClinicalTrials.gov: NCT05867251

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Advanced Solid Tumors

Version	Level	Code	Term	System organ class
21.1	LLT	10065252	Solid tumor	10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Avenzo Therapeutics Inc.

Sponsor organisation: Avenzo Therapeutics Inc.
Address: 12707 High Bluff Drive Suite 200
City: San Diego
Postcode: 92130-2037
Country: United States

Scientific contact point

Organisation: Avenzo Therapeutics Inc.
Contact name: Naresh Nayyar

Public contact point

Organisation: Avenzo Therapeutics Inc.
Contact name: Naresh Nayyar

Locations

5 EU/EEA countries · 32 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Authorised, recruitment pending	11	4
France	Authorised, recruitment pending	11	7
Germany	Authorised, recruitment pending	10	4
Italy	Authorised, recruitment pending	10	5
Spain	Authorised, recruitment pending	10	12
Rest of world Australia, Korea, Republic of, United States	—	302	—

Investigational sites

Belgium

4 sites · Authorised, recruitment pending

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur

Gynaecological oncology, Place Louise Godin 15, 5000, Namur

UZ Leuven

Gynaecological oncology, Herestraat 49, 3000, Leuven

Cliniques universitaires Saint-Luc

Gynaecological oncology, Avenue Hippocrate 10, 1200, Brussels

Antwerp University Hospital

Gynaecological oncology, Drie Eikenstraat 655, 2650, Edegem

France

7 sites · Authorised, recruitment pending

Institut Gustave Roussy

Department of Medecine, 114 Rue Edouard Vaillant, 94800, Villejuif

Centre Georges François Leclerc

Medical Oncology, 1 rue Professeur Marion, 21079, Dijon

Oncopole Claudius Regaud

Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9

Centre Leon Berard

Medical Oncology, 28 Rue Laennec, 69008, Lyon

Institut De Cancerologie De L Ouest

Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex

Institut Paoli Calmettes

Medical Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Institut Bergonié

Medical Oncology, 229 cours de l'Argonne, 33076, Bordeaux

Germany

4 sites · Authorised, recruitment pending

Universitaetsklinikum Erlangen AöR

Gynecology, Universitaetsstrasse 21-23, Innenstadt, Erlangen

University Hospital Düsseldorf

Gynecological oncology, Moorenstr. 5, 40225, Dusseldorf

Uniklinikum Leipzig

Gynecology, Liebigstrasse 20, 04103, Leipzig

Universitätsklinikum Augsburg

Gynacology, Stenglinstr. 2, 86156, Augsburg

Italy

5 sites · Authorised, recruitment pending

Istituto Europeo Di Oncologia S.r.l.

Divisione di Sviluppo Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Oncology Division, Corso Giuseppe Mazzini 18, 28100, Novara

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo

Azienda Ospedaliero Universitaria Delle Marche

Medicina Intenra - SOD Clinica Oncologica, Via Conca 71, 60126, Ancona

Azienda Ospedaliero Universitaria Di Modena

Oncology, Largo Del Pozzo 71, 41124, Modena

Spain

12 sites · Authorised, recruitment pending

Hospital Hm Nou Delfos

Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona

Clinica Universidad De Navarra

Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid

Hospital Beata Maria Ana

Medical Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid

Hospital General Universitario Gregorio Maranon

Medical Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid

Hospital Clinico San Carlos

Medical Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid

Hospital Universitario 12 De Octubre

Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid

Fundacion Instituto Valenciano De Oncologia

Medical Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia

Hospital Universitario Hm Sanchinarro

Medical Oncology, Calle Ona 10, 28050, Madrid

Hospital Universitari Vall D Hebron

Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

University Hospital Virgen Del Rocio S.L.

Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitario Fundacion Jimenez Diaz

Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid