Status:
NOT_YET_RECRUITING
Proof-of-Concept Study of ACT001 in Adult Patients With Recurrent Glioblastoma Harbouring STAT3-High Signature
Lead Sponsor:
National Neuroscience Institute
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This trial will study the effectiveness of ACT001 in adult patients whose Glioblastoma have recurred with a STAT3-high signature after standard-of-care treatment with at least radiation therapy.
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of GBM according to 2021 WHO classification
- Availability of tumor tissue representative of GBM from definitive surgery or biopsy and tested to harbour STAT3-High Signature
- Previous treatment with at least radiation therapy
- Documented recurrence of malignant glioma by diagnostic biopsy, resection or MRI performed within 21 days of study enrolment per RANO criteria.
- There is no limit on number of previous recurrences or lines of treatment
- At least 12 weeks after the end of prior radiation therapy is required unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) n new enhancement on MRI outside of the radiation treatment field
- An interval of at least 4 weeks after the last administration of any investigational agent or any other treatment prior to first dose of STAT3 inhibitor
- Age 21 years or older on the day of signing informed consent
- Karnofsky performance status (KPS) of 70 or higher
- Patient has adequate bone marrow, renal, and hepatic function ≤ 21 days prior to study enrolment (Step 2) as follows:
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin (Hgb) ≥ 9.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dL is acceptable.)
- Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault formula
- Hepatic function: Total bilirubin, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) ≤ 1.5 times upper limit of normal (ULN). Patients with Gilbert's syndrome documented in medical history may be enrolled if bilirubin is \< 3 times ULN.
Exclusion
- Presence of extracranial metastatic or leptomeningeal disease
- Previous or current treatment with a JAK or STAT3 inhibitor
- Previous or current treatment with bevacizumab/VEGF inhibitor
- Patient is a lactating or pregnant female.
- Symptomatic intra-tumoural haemorrhage
- Severe, active co-morbidity, defined as follows:
- Patients with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness.
- Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the Investigator may put the patient at high risk of toxicity
- Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06894225
Start Date
April 1 2025
End Date
May 1 2026
Last Update
April 6 2025
Active Locations (1)
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1
National Neuroscience Institute
Singapore, Singapore