Colorectal CancerPhase 1NCT04468607
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
A Phase 1 study testing BLYG8824A in people with Colorectal Cancer, run by Genentech, Inc. at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- BLYG8824A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Aug 2020to 16 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain3 sites
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, 28040
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
United States2 sites
City of Hope
Duarte, California, 91010
SCRI Oncology Partners
Nashville, Tennessee, 37203
About this study
Official 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
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.
- Conditions
- Colorectal Cancer
- Being tested
- BLYG8824A
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLYG8824ADrug
Also called linclatamig, RG6286
BLYG8824A will be administered at a flat dose independent of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation Stage | Experimental | Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD). Receives: Drug: BLYG8824A |
| Dose-Expansion Stage | Experimental | 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. Receives: Drug: BLYG8824A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Nature of DLTs
Measured: Approximately 48 months
Number of Patricipants with Adverse Events
Measured: Approximately 48 months
Number Of Cycles Received
Measured: Approximately 48 months
Dose Intensity
Measured: Approximately 48 months
Maximum Tolerated Dose(s) MTD(s) of BLYG8824A
Measured: Approximately 48 months
Secondary outcomes (4)
Serum Concentration of BLYG8824A
Measured: At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Approximately 48 months
Duration of Response (DOR)
Duration of response (DOR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Measured: Approximately 48 months
Presence of Anti-drug Antibodies (ADAs)
Measured: Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start31 Aug 2020
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468607
- Sponsor's protocol ID
- GO41751
- Other IDs
- 2023-503409-12-00, 2023
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2020
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04468607
- Acronym / sponsor ID
- GO41751
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation Stage | Experimental | Drug: BLYG8824AParticipants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD). |
| Dose-Expansion Stage | Experimental | Drug: BLYG8824AOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLYG8824AAlso: linclatamig, RG6286BLYG8824A will be administered at a flat dose independent of body weight. | Drug | Dose-Escalation Stage, Dose-Expansion Stage |
Primary outcome
Incidence and Nature of DLTs
Time frame: Approximately 48 months
Number of Patricipants with Adverse Events
Time frame: Approximately 48 months
Number Of Cycles Received
Time frame: Approximately 48 months
Dose Intensity
Time frame: Approximately 48 months
Maximum Tolerated Dose(s) MTD(s) of BLYG8824A
Time frame: Approximately 48 months
4 secondary outcomes
Serum Concentration of BLYG8824A
Time frame: At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Overall Response Rate (ORR)
Time frame: Approximately 48 months
Duration of Response (DOR)
Time frame: Approximately 48 months
Presence of Anti-drug Antibodies (ADAs)
Time frame: Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLYG8824A in people with Colorectal Cancer, run by Genentech, Inc. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Nature of DLTs (time frame: Approximately 48 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.