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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05487235
Registration number
NCT05487235
Ethics application status
Date submitted
21/07/2022
Date registered
4/08/2022
Date last updated
6/06/2024
Titles & IDs
Public 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
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Scientific title
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
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Secondary ID [1]
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2021-006479-40
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Secondary ID [2]
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GO43712
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Metastatic Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GDC-1971
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Omeprazole
Experimental: Dose-finding Stage: GDC-1971 - Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations.
Experimental: Expansion Stage: GDC-1971 - Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971.
Treatment: Drugs: GDC-1971
Capsule or tablet administered orally.
Treatment: Drugs: Atezolizumab
Administered as IV infusion.
Treatment: Drugs: Omeprazole
Administered orally as tablet or capsule in the acid-reducing agent assessment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 2.5 years
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Primary outcome [2]
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Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
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Assessment method [2]
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Timepoint [2]
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Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
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Primary outcome [3]
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Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results
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Assessment method [3]
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Timepoint [3]
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Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
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Primary outcome [4]
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Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)
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Assessment method [4]
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Timepoint [4]
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Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
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Primary outcome [5]
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Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
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Assessment method [5]
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Timepoint [5]
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From Day 1 to Day 21 of Cycle 1 of the dose finding stage
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Primary outcome [6]
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Plasma Concentration of GDC-1971
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2.5 years
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Secondary outcome [1]
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Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
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Assessment method [1]
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Timepoint [1]
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Up to approximately 2.5 years
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Secondary outcome [2]
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AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
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Assessment method [2]
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Timepoint [2]
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Up to approximately 2.5 years
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Secondary outcome [3]
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Cmax of GDC-1971 Following Capsule or Tablet Administration
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Assessment method [3]
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Timepoint [3]
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Up to approximately 2.5 years
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Secondary outcome [4]
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AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
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Assessment method [4]
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Timepoint [4]
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Up to approximately 2.5 years
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Secondary outcome [5]
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AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
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Assessment method [5]
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Timepoint [5]
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Up to approximately 2.5 years
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Secondary outcome [6]
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Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2.5 years
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Secondary outcome [7]
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AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2.5 years
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Secondary outcome [8]
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Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2.5 years
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Secondary outcome [9]
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Objective Response Rate (ORR)
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Assessment method [9]
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Timepoint [9]
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Up to approximately 2.5 years
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Secondary outcome [10]
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Duration of Response (DOR)
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Assessment method [10]
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Timepoint [10]
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Up to approximately 2.5 years
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Secondary outcome [11]
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Progression Free Survival (PFS)
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Assessment method [11]
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Timepoint [11]
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Up to approximately 2.5 years
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Secondary outcome [12]
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PFS Rate
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Assessment method [12]
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Timepoint [12]
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Month 6
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Secondary outcome [13]
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Overall Survival (OS) Rate
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Assessment method [13]
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Timepoint [13]
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Months 6 and 12
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2025
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Actual
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Sample size
Target
232
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Border Medical Oncology - Wodonga
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Recruitment hospital [3]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [4]
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Austin Hospital - Heidelberg
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Recruitment hospital [5]
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One Clinical Research Perth - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3690 - Wodonga
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Argentina
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State/province [2]
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Cordoba
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Country [3]
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Argentina
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State/province [3]
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La Rioja
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Country [4]
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Argentina
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State/province [4]
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Rosario
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Country [5]
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Brazil
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State/province [5]
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MG
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Country [6]
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Brazil
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State/province [6]
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PA
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Country [7]
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Brazil
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State/province [7]
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RS
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Country [8]
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Brazil
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State/province [8]
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SP
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Country [9]
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Canada
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State/province [9]
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Alberta
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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Korea, Republic of
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State/province [11]
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Cheongju si
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Country [12]
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Korea, Republic of
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State/province [12]
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Goyang-si
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Country [13]
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Korea, Republic of
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State/province [13]
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Seoul
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Country [14]
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Korea, Republic of
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State/province [14]
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Suwon-si
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Country [15]
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New Zealand
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State/province [15]
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Auckland
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Country [16]
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Poland
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State/province [16]
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Pozna?
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Country [17]
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Spain
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State/province [17]
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Madrid
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Country [18]
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Spain
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State/province [18]
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Navarra
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Country [19]
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Spain
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State/province [19]
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Barcelona
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Country [20]
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Spain
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State/province [20]
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Sevilla
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Country [21]
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Spain
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State/province [21]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genentech, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05487235
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Phone
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Fax
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Email
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Contact person for public queries
Name
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GO43712 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05487235
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