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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04250155




Registration number
NCT04250155
Ethics application status
Date submitted
29/01/2020
Date registered
31/01/2020

Titles & IDs
Public title
An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase Ia/Ib, Open-Label, Multicenter, Global, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of XmAb24306 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
GO41596
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XmAb24306
Treatment: Drugs - Atezolizumab
Treatment: Drugs - XmAb24306

Experimental: Phase 1a Dose Escalation - Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Experimental: Phase 1a Dose Expansion - Participants will receive XmAb24306 until study treatment discontinuation or study termination.

Experimental: Phase 1b Dose Escalation - Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.

Experimental: Phase 1b Dose Expansion - Participants will receive XmAb24306 and atezolizumab until study treatment discontinuation or study termination.


Treatment: Drugs: XmAb24306
Participants will receive intravenous (IV) XmAb24306.

Treatment: Drugs: Atezolizumab
Participants will receive IV XmAb24306 followed by IV atezolizumab

Treatment: Drugs: XmAb24306
Participants will receive IV XmAb24306 followed by IV atezolizumab.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events
Timepoint [1] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Serum Concentration of XmAb24306
Timepoint [1] 0 0
Baseline, then at pre-defined intervals for the first year of treatment or until participant discontinues study treatment
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [2] 0 0
Up to approximately 4 years
Secondary outcome [3] 0 0
Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
Timepoint [3] 0 0
Up to approximately 4 years
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1
Timepoint [4] 0 0
Up to approximately 4 years
Secondary outcome [5] 0 0
ORR as Based on Radiographic Assessment by the Investigator Using Modified RECIST v1.1 for Immune-Based Therapeutics (iRECIST)
Timepoint [5] 0 0
Up to approximately 4 years
Secondary outcome [6] 0 0
DOR as Based on Radiographic Assessment by the Investigator Using iRECIST
Timepoint [6] 0 0
Up to approximately 4 years
Secondary outcome [7] 0 0
PFS as Based on Radiographic Assessment by the Investigator Using iRECIST
Timepoint [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to approximately 4 years

Eligibility
Key inclusion criteria
Key General Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy >/= 12 weeks
* Adequate hematologic and end-organ function
* For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
* Negative serum pregnancy test for women of childbearing potential
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Availability of representative tumor specimens

Key General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Pregnant or breastfeeding, or intending to become pregnant during the study
* Significant cardiovascular disease
* Current treatment with medications that prolong the QT interval
* Known clinically significant liver disease
* Poorly controlled Type 2 diabetes mellitus
* Symptomatic, untreated, or actively progressing CNS metastases
* History of leptomeningeal disease
* History of malignancy other than disease under study within 3 years prior to screening
* Active or history of autoimmune disease or immune deficiency
* Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
* Positive for HIV infection
* Prior allogeneic stem cell or solid organ transplantation

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
9/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/09/2025
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter Mac Callum Cancer Center - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Wilrijk
Country [8] 0 0
Brazil
State/province [8] 0 0
MG
Country [9] 0 0
Brazil
State/province [9] 0 0
PA
Country [10] 0 0
Brazil
State/province [10] 0 0
PR
Country [11] 0 0
Brazil
State/province [11] 0 0
RS
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Italy
State/province [15] 0 0
Lombardia
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seongnam-si
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Netherlands
State/province [19] 0 0
Groningen
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
Cordoba
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Spain
State/province [24] 0 0
Valencia

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
Reference Study ID Number: GO41596 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
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).
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/NCT04250155