Clinical trial · Interventional
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic 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
NCT04468607CI-TRIAL-00088930completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLYG8824A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose-Escalation Stage
- description
- Participants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
- interventionNames
- Drug: BLYG8824A
- type
- EXPERIMENTAL
- label
- Dose-Expansion Stage
- description
- 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.
- interventionNames
- Drug: BLYG8824A
Primary outcomes (5)
- measure
- Incidence and Nature of DLTs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.