A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

CompletadoFase 1ClinicalTrials.gov

ID: NCT05487235Tipo: INTERVENTIONALInicio: 17 de ago de 2022Fin estimado: 23 de jun de 2025

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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).
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
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
Histologically confirmed recurrent, or metastatic HNSCC
PD-L1 positive
No prior systemic therapy for recurrent or metastatic HNSCC
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
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

Criterios de exclusión

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

Intervenciones

drug

GDC-1971

Capsule or tablet administered orally.

drug

Atezolizumab

Administered as IV infusion.

drug

Omeprazole

Administered orally as tablet or capsule in the acid-reducing agent assessment.

Ubicaciones

Sanatorio Allende

Córdoba, Argentina

Fundacion CORI para la Investigacion y Prevencion del Cancer

La Rioja, Argentina

Centro Medico IPAM

Rosario, Argentina

Patrocinadores

PrincipalGenentech, Inc.

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