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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Capsule or tablet administered orally.
Administered as IV infusion.
Administered orally as tablet or capsule in the acid-reducing agent assessment.
Sanatorio Allende
Córdoba, Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer
La Rioja, Argentina
Centro Medico IPAM
Rosario, Argentina
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Border Medical Oncology
Wodonga, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
One Clinical Research Perth
Nedlands, Western Australia, Australia
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Pará, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre, Pará, Brazil
...and 15 more locations
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2.5 years
Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)
Time frame: Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Plasma Concentration of GDC-1971
Time frame: Up to approximately 2.5 years
Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
Cmax of GDC-1971 Following Capsule or Tablet Administration
Time frame: Up to approximately 2.5 years
AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
Time frame: Up to approximately 2.5 years
AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Time frame: Up to approximately 2.5 years
Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Time frame: Up to approximately 2.5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2.5 years
Duration of Response (DOR)
Time frame: Up to approximately 2.5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 2.5 years
PFS Rate
Time frame: Month 6
Overall Survival (OS) Rate
Time frame: Months 6 and 12
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