Trial Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05487235
Condition:
Advanced Solid Tumors
Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Atezolizumab
Omeprazole
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GDC-1971
Description:
Capsule or tablet administered orally.
Arm group label:
Dose-finding Stage: GDC-1971
Arm group label:
Expansion Stage: GDC-1971
Other name:
RO7517834, RLY-1971
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Administered as IV infusion.
Arm group label:
Dose-finding Stage: GDC-1971
Arm group label:
Expansion Stage: GDC-1971
Other name:
RO5541267
Intervention type:
Drug
Intervention name:
Omeprazole
Description:
Administered orally as tablet or capsule in the acid-reducing agent assessment.
Arm group label:
Expansion Stage: GDC-1971
Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity
of GDC-1971 when administered in combination with atezolizumab in participants with
locally advanced or metastatic solid tumors.
The study will have 2 stages- dose finding stage and expansion stage. In expansion stage
participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD
L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1
positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid
tumors will be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1
- Has Life expectancy >= 12 weeks
- Adequate organ function
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1
(RECIST v1.1).
Inclusion Criteria for Dose-Finding Stage:
- Histologically confirmed locally advanced or metastatic solid tumor that has
progressed after at least one available standard therapy or for which approved
standard therapy has proven to be ineffective or intolerable
Inclusion Criteria for Expansion Stage: NSCLC Cohort
- Histologically confirmed locally advanced or metastatic NSCLC
- Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase
(ALK)
- PD- L1 positive
- No prior systemic therapy for locally advanced or metastatic NSCLC
Inclusion Criteria for Expansion Stage: HNSCC Cohort
- Histologically confirmed recurrent, or metastatic HNSCC
- PD-L1 positive
- No prior systemic therapy for recurrent or metastatic HNSCC
Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort
- Histologically confirmed locally advanced or metastatic or unresectable locally
advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are
non-mucosal and non -uveal that has progressed on or after treatment that included
anti PD1 or anti PD-L1 therapy
Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort
- Histologically confirmed locally advanced or metastatic solid tumor that has
progressed after at least one available standard therapy or for which approved
standard therapy has proven to be ineffective or intolerable, standard therapy is
considered inappropriate, or an investigational agent is a recognized standard of
care
Exclusion Criteria:
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases.
- Has leptomeningeal disease or carcinomatous meningitis
- Has uncontrolled hypertension
- Has left ventricular ejection fraction < institutional lower limit of normal or <
50%
- Has clinically significant history of liver disease including viral or other
hepatitis, current alcohol abuse, or cirrhosis
- Has an active or history of autoimmune disease or immune deficiency including
myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,
rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated
with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,
Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis.
Participants with a history of autoimmune- related hypothyroidism on thyroid
replacement hormone or with controlled Type I diabetes mellitus on a stable dose of
an insulin regimen are eligible for this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Withdrawn
Facility:
Name:
Sanatorio Allende
Address:
City:
Cordoba
Zip:
X5000JHQ
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Fundacion CORI para la Investigacion y Prevencion del Cancer
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro Medico IPAM
Address:
City:
Rosario
Zip:
S2013SBK
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Centro de Investigación Clínica ? Clínica Viedma
Address:
City:
Viedma
Zip:
R8500ACE
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
St Vincent's Hospital Sydney
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Border Medical Oncology
Address:
City:
Wodonga
Zip:
3690
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research Perth
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Santa Casa de Misericordia de Belo Horizonte - PPDS
Address:
City:
Belo Horizonte
Zip:
30150-221
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital de Clinicas de Porto Alegre HCPA PPDS
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Universidade de Caxias do Sul
Address:
City:
Caxias Do Sul
Zip:
95070-561
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
ONCOSITE Centro de Pesquisa Clínica Em Oncologia
Address:
City:
Ijuí
Zip:
98700-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Fundacao Pio XII Hospital de Cancer de Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundação Doutor Amaral Carvalho - Hospital Amaral
Address:
City:
JAU
Zip:
17210-080
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
Address:
City:
Sao Jose Do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Instituto Brasileiro de Controle Do Câncer IBCC
Address:
City:
São Paulo
Zip:
03102-006
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Ottawa Hospital
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 1Z5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center - PPDS
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea Seoul St. Mary?s Hospital
Address:
City:
Seoul
Zip:
6591
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
The Catholic University of Korea St. Vincent's Hospital
Address:
City:
Suwon
Zip:
442-723
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Auckland City Hospital
Address:
City:
Auckland
Zip:
1124
Country:
New Zealand
Status:
Active, not recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny w Poznaniu
Address:
City:
Pozna?
Zip:
60-335
Country:
Poland
Status:
Withdrawn
Facility:
Name:
NEXT Oncology-Hospital Quironsalud Madrid
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Withdrawn
Facility:
Name:
MD Anderson Cancer Center Madrid ? Espana
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Clinica Universitaria Navarra (Madrid)
Address:
City:
Madrid
Zip:
28036
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Chi Mei Medical Center Liou Ying Campus
Address:
City:
Liuying Township
Zip:
736
Country:
Taiwan
Status:
Withdrawn
Facility:
Name:
China Medical University Hospital
Address:
City:
North Dist.
Zip:
40402
Country:
Taiwan
Status:
Withdrawn
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei City
Zip:
11217
Country:
Taiwan
Status:
Withdrawn
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Withdrawn
Start date:
August 17, 2022
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487235
