A study evaluating the safety, tolerability, pharmacokinetics, and activity of RO7566802 given alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumor malignancies

2023-509266-38-00 Protocol GO44431 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 2 EU/EEA countries · 7 sites · Protocol GO44431

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 134
Countries 2
Sites 7

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]
Decision date (initial)
2025-02-24
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Locally Advanced or Metastatic Solid Tumors

VersionLevelCodeTermSystem organ class
20.0 PT 10033128 Ovarian cancer 100000004864
27.0 PT 10057529 Ovarian cancer metastatic 100000004864
21.0 PT 10073251 Clear cell renal cell carcinoma 100000004864
20.1 LLT 10080007 Clear cell renal cell carcinoma metastatic 10029104
21.1 LLT 10065252 Solid tumor 10029104
21.1 LLT 10065147 Malignant 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

2 EU/EEA countries · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Authorised, recruitment pending 8 2
Spain Authorised, recruitment pending 15 5
Rest of world
Singapore, United States, United Kingdom, Australia, Korea, Republic of, Canada
111

Investigational sites

Czechia

2 sites · Authorised, recruitment pending
University Hospital Olomouc
n/a, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
n/a, Zluty Kopec 543/7, Stare Brno, Brno-Stred

Spain

5 sites · Authorised, recruitment pending
Clinica Universidad De Navarra
Servicio de oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario De Valencia
Servicio de oncologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Servicio de oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Servicio de oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-22 Spain Acceptable with conditions
2025-02-18
2025-02-18
2 SUBSTANTIAL MODIFICATION SM-1 2025-10-02 Spain Acceptable
2025-11-18
2025-11-19
3 SUBSTANTIAL MODIFICATION SM-2 2026-02-03 Spain Acceptable
2026-03-23
2026-03-25