Description:
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.
Title
- Brief Title: A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
GO41751
- NCT ID:
NCT04468607
Conditions
Interventions
Drug | Synonyms | Arms |
---|
BLYG8824A | | Dose-Escalation Stage |
Purpose
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 Arms
Name | Type | Description | Interventions |
---|
Dose-Escalation Stage | Experimental | Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD). | |
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. | |
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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and Nature of DLTs |
Time Frame: | Approximately 48 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | |
Measure: | Overall Response Rate (ORR) |
Time Frame: | Approximately 48 months |
Safety Issue: | |
Description: | 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) |
Measure: | Duration of Response (DOR) |
Time Frame: | Approximately 48 months |
Safety Issue: | |
Description: | 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 |
Measure: | 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) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genentech, Inc. |
Last Updated
July 26, 2021