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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05487235




Registration number
NCT05487235
Ethics application status
Date submitted
21/07/2022
Date registered
4/08/2022

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
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
Secondary ID [1] 0 0
2021-006479-40
Secondary ID [2] 0 0
GO43712
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 2.5 years
Primary outcome [2] 0 0
Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs
Timepoint [2] 0 0
Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Primary outcome [3] 0 0
Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results
Timepoint [3] 0 0
Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Primary outcome [4] 0 0
Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)
Timepoint [4] 0 0
Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)
Primary outcome [5] 0 0
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Timepoint [5] 0 0
From Day 1 to Day 21 of Cycle 1 of the dose finding stage
Primary outcome [6] 0 0
Plasma Concentration of GDC-1971
Timepoint [6] 0 0
Up to approximately 2.5 years
Secondary outcome [1] 0 0
Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration
Timepoint [1] 0 0
Up to approximately 2.5 years
Secondary outcome [2] 0 0
AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration
Timepoint [2] 0 0
Up to approximately 2.5 years
Secondary outcome [3] 0 0
Cmax of GDC-1971 Following Capsule or Tablet Administration
Timepoint [3] 0 0
Up to approximately 2.5 years
Secondary outcome [4] 0 0
AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Timepoint [4] 0 0
Up to approximately 2.5 years
Secondary outcome [5] 0 0
AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions
Timepoint [5] 0 0
Up to approximately 2.5 years
Secondary outcome [6] 0 0
Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions
Timepoint [6] 0 0
Up to approximately 2.5 years
Secondary outcome [7] 0 0
AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Timepoint [7] 0 0
Up to approximately 2.5 years
Secondary outcome [8] 0 0
Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole
Timepoint [8] 0 0
Up to approximately 2.5 years
Secondary outcome [9] 0 0
Objective Response Rate (ORR)
Timepoint [9] 0 0
Up to approximately 2.5 years
Secondary outcome [10] 0 0
Duration of Response (DOR)
Timepoint [10] 0 0
Up to approximately 2.5 years
Secondary outcome [11] 0 0
Progression Free Survival (PFS)
Timepoint [11] 0 0
Up to approximately 2.5 years
Secondary outcome [12] 0 0
PFS Rate
Timepoint [12] 0 0
Month 6
Secondary outcome [13] 0 0
Overall Survival (OS) Rate
Timepoint [13] 0 0
Months 6 and 12

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
232
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
One Clinical Research Perth - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3690 - Wodonga
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
La Rioja
Country [5] 0 0
Argentina
State/province [5] 0 0
Rosario
Country [6] 0 0
Argentina
State/province [6] 0 0
Viedma
Country [7] 0 0
Brazil
State/province [7] 0 0
MG
Country [8] 0 0
Brazil
State/province [8] 0 0
PA
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Cheongju-si
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Goyang-si
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Suwon
Country [17] 0 0
New Zealand
State/province [17] 0 0
Auckland
Country [18] 0 0
Poland
State/province [18] 0 0
Pozna?
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Navarra
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Sevilla
Country [23] 0 0
Spain
State/province [23] 0 0
Valencia
Country [24] 0 0
Taiwan
State/province [24] 0 0
Liuying Township
Country [25] 0 0
Taiwan
State/province [25] 0 0
North Dist.
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GO43712 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05487235