Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
116
Countries
3
Sites
15
Locally Advanced or Metastatic Solid Tumors
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2025 → 9 Dec 2025
- Decision date (initial)
- 2025-04-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic 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
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 4 |
| Italy | Ended | 10 | 4 |
| Spain | Ended | 10 | 7 |
| Rest of world
United States, Australia, Korea, Republic of, Canada
|
— | 84 | — |
Investigational sites
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Curie
Department of Drug Development and Innovation, 26 Rue D Ulm, 75005, Paris
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Ospedale San Raffaele S.r.l.
U.O. Oncologia Medica, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Istituto Nazionale Dei Tumori
Immunotherapy and Anticancer Innovative Therapeutics Unit S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Humanitas Mirasole S.p.A.
Medical Oncology and Hematology Phase I Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità di Fase 1 - Unità di Farmacologia Clinica, Largo Francesco Vito 1, 00168, Rome
Hospital Clinico Universitario De Valencia
Medical Oncology Department, Avenida Blasco Ibanez 17, 46010, Valencia
Clinica Universidad De Navarra
Medical Oncology Department, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology Department, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Medical Oncology Department, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Medical Oncology Department (VHIO), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Spain | 2025-05-27 | 2025-06-24 | 2025-09-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-96351
- Halt date
- 2025-08-25
- Member states concerned
- Spain
- Publication date
- 2025-09-03
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results), Medicinal Product related
- Explanation
- Following the report of a related Grade 5 event, protocol-defined study stopping criteria were met and the ISC made the decision to halt dosing and enrolment of Study GO45296.
- Follow-up measures
- Immediately halt all dosing and enrolment activities.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-08 | Spain | Acceptable 2025-04-21
|
2025-04-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-06 | Spain | Acceptable 2025-04-21
|
2025-05-06 |