Program Status
Active, not recruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
Atezolizumab, GDC-1971, OmeprazoleTags
MSI-H/ MMRd, MSS/ MMRpComments
Trial for advanced or metastatic solid tumor, CRC included, that has progressed after at least one line of therapy.
Combination of an anti SHP2 with immunotherapy:
GDC-1971: SHP2 inhibitor. SHP2 promotes cancer cell survival and growth through the RAS pathway by transducing signals downstream from receptor tyrosine kinases (RTKs); this experimental inhibitor targets SHP2. It will be administrated as tablet or capsule in the trial.
Atezolizumab (Tecentriq®): PD-L1 checkpoint inhibitor; immunotherapy
In the expansion stage, Omeprazole (acid-reducing agent) will be added to the combination.
Even if the trial does not requiere particular mutations, trial might be of interest for KRAS and BRAF mutant, give the potential role of SHP2 inhibitors on their treatment. See Helpful Links
| Location | Location Status |
|---|---|
| Argentina | |
|
Sanatorio Allende Cordoba X5000JHQ |
Active, not recruiting |
|
Fundacion CORI para la Investigacion y Prevencion del Cancer La Rioja F5300COE |
Active, not recruiting |
|
Centro Medico IPAM Rosario S2013SBK |
Active, not recruiting |
| Australia | |
|
St Vincent's Hospital Sydney Darlinghurst, New South Wales 2010 |
Active, not recruiting |
|
Border Medical Oncology Wodonga, New South Wales 3690 |
Active, not recruiting |
|
Flinders Medical Centre Bedford Park, South Australia 5042 |
Active, not recruiting |
|
Austin Hospital Heidelberg, Victoria 3084 |
Active, not recruiting |
|
One Clinical Research Perth Nedlands, Western Australia 6009 |
Active, not recruiting |
| Brazil | |
|
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner Curitiba, Pará 81520-060 |
Active, not recruiting |
|
Hospital de Clinicas de Porto Alegre HCPA PPDS Porto Alegre, Pará 90035-903 |
Active, not recruiting |
|
Universidade de Caxias do Sul Caxias Do Sul, Rio Grande Do Sul 95070-561 |
Active, not recruiting |
|
Fundacao Pio XII Hospital de Cancer de Barretos Barretos, São Paulo 14784-400 |
Active, not recruiting |
|
Fundação Doutor Amaral Carvalho - Hospital Amaral JAU, São Paulo 17210-080 |
Active, not recruiting |
|
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Sao Jose Do Rio Preto, São Paulo 15090-000 |
Active, not recruiting |
|
Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo, São Paulo 01246-000 |
Active, not recruiting |
|
Instituto Brasileiro de Controle Do Câncer IBCC São Paulo 03102-006 |
Active, not recruiting |
| Canada | |
|
Cross Cancer Institute Edmonton, Alberta T6G 1Z2 |
Active, not recruiting |
|
Ottawa Hospital Ottawa, Ontario K1H 8L6 |
Active, not recruiting |
|
Princess Margaret Cancer Centre Toronto, Ontario M5G 2M9 |
Active, not recruiting |
| Korea, Republic of | |
|
Chungbuk National University Hospital Cheongju-si 28644 |
Active, not recruiting |
|
National Cancer Center Goyang-si 10408 |
Active, not recruiting |
|
Seoul National University Hospital Seoul 03080 |
Active, not recruiting |
|
Severance Hospital, Yonsei University Health System Seoul 03722 |
Active, not recruiting |
|
Asan Medical Center - PPDS Seoul 05505 |
Active, not recruiting |
|
The Catholic University of Korea St. Vincent's Hospital Suwon-si 16247 |
Active, not recruiting |
| New Zealand | |
|
Auckland City Hospital Auckland 1023 |
Active, not recruiting |
Inclusion 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
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
