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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/NCT04468607




Registration number
NCT04468607
Ethics application status
Date submitted
23/06/2020
Date registered
13/07/2020
Date last updated
19/03/2024

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 hospital [2] 0 0
The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - 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
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Spain
State/province [4] 0 0
Navarra
Country [5] 0 0
Spain
State/province [5] 0 0
Barcelona
Country [6] 0 0
Spain
State/province [6] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics of BLYG8824A and will
make a preliminary assessment of the anti-tumor activity of BLYG8824A in patients with
locally advanced or metastatic colorectal cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04468607
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04468607