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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04468607
Collaborator
(none)
60
Enrollment
6
Locations
2
Arms
64.1
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 31, 2020
Anticipated Primary Completion Date :
Jan 2, 2026
Anticipated Study Completion Date :
Jan 2, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose-Escalation Stage

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Incidence and Nature of DLTs [Approximately 48 months]

  2. Number of Patricipants with Adverse Events [Approximately 48 months]

  3. Number Of Cycles Received [Approximately 48 months]

  4. Dose Intensity [Approximately 48 months]

  5. Maximum Tolerated Dose(s) MTD(s) of BLYG8824A [Approximately 48 months]

Secondary Outcome Measures

  1. Serum Concentration of BLYG8824A [At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)]

  2. Overall Response Rate (ORR) [Approximately 48 months]

    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)

  3. Duration of Response (DOR) [Approximately 48 months]

    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

  4. Presence of Anti-drug Antibodies (ADAs) [Cycle 1, Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 City of Hope Duarte California United States 91010
2 Sarah Cannon Research Institute Nashville Tennessee United States 37203
3 Peter MacCallum Cancer Centre; Medical Oncology Melbourne Victoria Australia 3000
4 Clinica Universitaria de Navarra Pamplona Navarra Spain 31008
5 Hospital Universitario Vall d'Hebron - PPDS Barcelona Spain 08035
6 START Madrid-FJD, Hospital Fundacion Jimenez Diaz Madrid Spain 28040

Sponsors and Collaborators

  • Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT04468607
Other Study ID Numbers:
  • GO41751
First Posted:
Jul 13, 2020
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Aug 3, 2022