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OncoMatch/Clinical Trials/NCT06917885

CUE-102 in Recurrent Glioblastoma

Is NCT06917885 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CUE-102 for recurrent glioblastoma.

Phase 1RecruitingDavid Reardon, MDNCT06917885Data as of May 2026

Treatment: CUE-102The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM). The name of the study drug involved in this study is: -CUE-102 (a type of fusion protein)

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage GRADE 4 (WHO)

Grade: 4 (WHO)

WHO Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence

Prior therapy

Must have received: radiation therapy (temozolomide) — initial

Patients must have fully completed initial radiation therapy with or without daily temozolomide including 60 Gy in 30 fractions, 59.4 Gy in 1.8 Gy per fraction or equivalent

Cannot have received: therapy for tumor recurrence other than surgery

Received any therapy for tumor recurrence other than surgery

Cannot have received: more than one episode of recurrent or progressive tumor

More than one episode of recurrent or progressive tumor

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)

Kidney function

Serum creatinine ≤ 1.5 X institutional ULN OR Measured or calculated creatinine clearance (CrCl) ≥45 mL/min for participant with creatinine levels > 1.5 X institutional ULN

Liver function

Serum total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for participants with total bilirubin levels > 1.5 X institutional ULN; AST (SGOT) and ALT (SGPT) ≤ 3.0 X institutional ULN OR ≤ 5 X institutional ULN for participants with Gilberts syndrome

Participants must meet the following organ and marrow function as defined below, all screening labs should be performed within 14 days of registration: Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks); Serum creatinine ≤ 1.5 X institutional ULN OR Measured or calculated creatinine clearance (CrCl) ≥45 mL/min for participant with creatinine levels > 1.5 X institutional ULN (CrCl should be calculated per institutional standard, GFR can also be used in place of creatinine or CrCl); Serum total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for participants with total bilirubin levels > 1.5 X institutional ULN; AST (SGOT) and ALT (SGPT) ≤ 3.0 X institutional ULN OR ≤ 5 X institutional ULN for participants with Gilberts syndrome; International Normalized Ratio (INR) OR Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 X institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants; Resting baseline oxygen saturation by pulse oximetry ≥92% at rest

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Brigham and Women's Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts

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