Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
348
Countries
5
Sites
44
Subjects with Aadvanced solid tumors for whom life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Single-agent XB002 will be evaluated up to 10 tumor types, and combination treatment will also be evaluated with nivolumab in NSCLC, SCCHN, and esophageal SCC, and for XB002 plus bevacizumab in EOC.
Key facts
- Sponsor
- Exelixis Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Aug 2023 → 11 Mar 2025
- Decision date (initial)
- 2024-09-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508267-69-00
- EudraCT number
- 2021-006543-10
- ClinicalTrials.gov
- NCT04925284
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Subjects with Aadvanced solid tumors for whom life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Single-agent XB002 will be evaluated up to 10 tumor types, and combination treatment will also be evaluated with nivolumab in NSCLC, SCCHN, and esophageal SCC, and for XB002 plus bevacizumab in EOC.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
| 20.0 | PT | 10039491 | Sarcoma | 100000004864 |
| 21.0 | LLT | 10030151 | Oesophageal cancer | 10029104 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 23.0 | LLT | 10084066 | Triple negative breast cancer metastatic | 10029104 |
| 21.0 | PT | 10041823 | Squamous cell carcinoma | 100000004864 |
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
| 21.0 | LLT | 10033604 | Pancreatic cancer | 10029104 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Exelixis Inc.
- Sponsor organisation
- Exelixis Inc.
- Address
- 1851 Harbor Bay Parkway
- City
- Alameda
- Postcode
- 94502-3010
- Country
- United States
Scientific contact point
- Organisation
- Exelixis Inc.
- Contact name
- Kanika Asija
Public contact point
- Organisation
- Exelixis Inc.
- Contact name
- Kanika Asija
Locations
5 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 26 | 6 |
| France | Ended | 34 | 11 |
| Italy | Ended | 34 | 8 |
| Netherlands | Ended | 9 | 4 |
| Spain | Ended | 119 | 15 |
| Rest of world
Korea, Republic of, Australia, United States, United Kingdom
|
— | 126 | — |
Investigational sites
Institut Jules Bordet
Dept of Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Cliniques Universitaires Saint-Luc
Dept of Medical Oncology/Institut Roi Albert II, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre hospitalier universitaire de Liege
Oncology Dept., Avenue De L'hopital 1, 4000, Liege
Universitair Ziekenhuis Gent
Dept of Medical Oncology, Corneel Heymanslaan 10, 9000, Gent
Grand Hopital De Charleroi
Dept of Medical Oncology, Grand'rue 3, 6000, Charleroi
Antwerp University Hospital
Dept of Oncology, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier Universitaire De Poitiers
Département d’Oncologie Médicale, 2 Rue De La Miletrie, 86000, Poitiers
Institut De Cancerologie Strasbourg Europe
Départementd’Oncologie Médicale, 17 Rue Albert Calmette, 67200, Strasbourg
Assistance Publique Hopitaux De Paris
Départementd’Oncologie Médicale, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Institut Curie
Départementd’Oncologie Médicale, 26 Rue D Ulm, 75005, Paris
Hospices Civils De Lyon
Département d’Oncologie Médicale – 1F, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Institut Paoli Calmettes
Département ONCO Médical 1, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
Départementd’Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Département des Innovations Thérapeutiques et Essais Précoces - DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Départementd’Oncologie Médicale, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Service d’Oncologie Médicale/Centred’Essais Précoces en Cancérologie, 20 Rue Leblanc, 75015, Paris
Centre De Lutte Contre Le Cancer Eugene Marquis
Départementd’Oncologie Médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Careggi University Hospital
SODc Medical Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Europeo Di Oncologia S.r.l.
Early Drug Development Division, Department of Oncology and Hematology Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Gynecologic Oncology Unit, Largo Francesco Vito 1, 00168, Rome
Humanitas Mirasole S.p.A.
Humanitas Cancer Center - Medical Oncology Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Phase I, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinical Oncology, Via Conca 71, 60126, Ancona
I.F.O. Istituti Fisioterapici Ospitalieri
Medical Oncology Unit, Via Elio Chianesi N 53, 00144, Rome
Ospedale San Raffaele S.r.l.
Department Medical Oncology, Via Olgettina 60, 20132, Milan
Academisch Ziekenhuis Maastricht
Dept of Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dept of Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Groningen
Dept of Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Netherlands Cancer Institute
Dept of Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Medical Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-10-17 | 2024-12-17 | 2023-11-30 | 2024-07-22 | |
| France | 2023-10-13 | 2024-12-02 | 2023-11-24 | 2024-08-05 | |
| Italy | 2023-10-30 | 2025-03-10 | 2023-11-15 | 2024-07-23 | |
| Netherlands | 2023-11-10 | 2024-11-27 | 2023-12-12 | 2024-07-25 | |
| Spain | 2023-08-11 | 2025-02-03 | 2023-08-30 | 2024-07-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-06 | Belgium | Acceptable with conditions 2024-09-09
|
2024-09-09 |