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

NCT ID: NCT04468607

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2024-10-16

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-Escalation Stage

Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).

Group Type: EXPERIMENTAL

BLYG8824A

Intervention Type: DRUG

BLYG8824A will be administered at a flat dose independent of body weight.

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.

Group Type: EXPERIMENTAL

BLYG8824A

Intervention Type: DRUG

BLYG8824A will be administered at a flat dose independent of body weight.

Interventions

BLYG8824A

BLYG8824A will be administered at a flat dose independent of body weight.

Intervention Type: DRUG

Other Intervention Names

linclatamig; RG6286

Eligibility 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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

City of Hope

Duarte, California, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , Spain

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid, , Spain

Countries

United States; Australia; Spain

Other Identifiers

2023-503409-12-00

Identifier Type: CTIS

Identifier Source: secondary_id

GO41751

Identifier Type: -

Identifier Source: org_study_id