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Closed (no longer recruiting)Last updated: 30 April 2024

This phase I study is trying to understand how safe, tolerable and effective a new anti-cancer drug (BLYG8824A) is in people with colorectal cancer.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 summary

Summary

This is a non-randomised trial with two experimental stages.

In the Dose Escalation Stage, participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).

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

Conditions

This trial is treating patients with colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Genentech

Scientific 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

Eligibility

Inclusion

  • 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
  • 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

  • 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

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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