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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04468607




Registration number
NCT04468607
Ethics application status
Date submitted
23/06/2020
Date registered
13/07/2020

Titles & IDs
Public title
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
Scientific title
A Phase I, Open-Label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of BLYG8824A Administered Intravenously In Patients With Locally Advanced Or Metastatic Colorectal Cancer
Secondary ID [1] 0 0
GO41751
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLYG8824A

Experimental: Dose-Escalation Stage - Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).

Experimental: Dose-Expansion Stage - Once dose escalation is completed and the MTD (or MAD) has been identified, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.


Treatment: Drugs: BLYG8824A
BLYG8824A will be administered at a flat dose independent of body weight.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Nature of DLTs
Timepoint [1] 0 0
Approximately 48 months
Primary outcome [2] 0 0
Number of Patricipants with Adverse Events
Timepoint [2] 0 0
Approximately 48 months
Primary outcome [3] 0 0
Number Of Cycles Received
Timepoint [3] 0 0
Approximately 48 months
Primary outcome [4] 0 0
Dose Intensity
Timepoint [4] 0 0
Approximately 48 months
Primary outcome [5] 0 0
Maximum Tolerated Dose(s) MTD(s) of BLYG8824A
Timepoint [5] 0 0
Approximately 48 months
Secondary outcome [1] 0 0
Serum Concentration of BLYG8824A
Timepoint [1] 0 0
At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles = 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Approximately 48 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Approximately 48 months
Secondary outcome [4] 0 0
Presence of Anti-drug Antibodies (ADAs)
Timepoint [4] 0 0
Cycle 1, Day 1; Cycle 2 Day 1; Cycles = 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)

Eligibility
Key inclusion criteria
* ECOG performance status of 0 or 1
* Life expectancy of at least 12 weeks
* Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC
* Locally advanced or metastatic CRC that has relapsed or is refractory to established therapies
* Prior disease progression (or intolerance) following oxaliplatin, irinotecan, fluoropyrimidines, and anti-EGFR monoclonal antibodies
* An archival tissue specimen or fresh baseline biopsy (when archival is not available) is required for enrollment into the study
* Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Non-measurable evaluable disease is acceptable for dose-escalation.
* Adequate hematologic and end organ function
* Acute, clinically significant treatment-related toxicity from prior therapy resolved to Grade = 1 prior to study entry

Expansion Cohort-Specific Inclusion Criteria

* MSS or MSI-L disease as determined by polymerase chain reaction (PCR) and/or IHC
* Measurable disease by RECIST v1.1 with at least one measurable target lesion in the expansion cohort
* Progression must have occurred during or after most recent treatment for locally advanced or metastatic colorectal cancer
* For patients enrolled in either a dedicated biopsy cohort or other expansion cohorts where biopsy is clinically feasible, willingness to consent to mandatory fresh pretreatment and on-treatment biopsies of safely accessible tumor lesions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of BLYG8824A
* Significant cardiopulmonary dysfunction
* Known clinically significant liver disease
* Positive serologic or PCR test results for acute or chronic HBV infection
* Acute or chronic HCV infection
* HIV seropositivity
* Poorly controlled Type 2 diabetes mellitus
* Current treatment with medications that are well known to prolong the QT interval
* Primary CNS malignancy, untreated CNS metastases, or active CNS metastases
* Leptomeningeal disease
* Spinal cord compression that has not been definitively treated with surgery and/or radiation
* History of autoimmune disease
* 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/01/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
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
Tennessee
Country [3] 0 0
Spain
State/province [3] 0 0
Navarra
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid

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
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/members/ourmembers/). 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/NCT04468607