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

• Status: Recruiting
• Trial end date: 2026-01-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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