A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer

STATUS

Recruiting
End date

Jan 2, 2026
participants needed

60
sponsor

Genentech, Inc.

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Updated on 19 February 2024

See if I qualify

measurable disease

solid tumour

monoclonal antibodies

oxaliplatin

irinotecan

PCR test

combination therapy

fluoropyrimidine

metastatic colorectal cancer

antibody therapy

colorectal cancer

EGFR

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.

Details

Condition	Colorectal Cancer, Colorectal Cancer, Rectal disorder
Age	18years - 100years
Treatment	BLYG8824A
Clinical Study Identifier	NCT04468607
Sponsor	Genentech, Inc.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
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

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A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer