Proof-of-Concept Study of ACT001 in Adult Patients with Recurrent Glioblastoma Harbouring STAT3-High Signature

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 randomization 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 randomization (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 Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06894225
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Neuroscience Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Singapore
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: ACT001

Interventions

Drug: - ACT001

Patients recruited and have signed informed consent will be initiated on ACT001 400mg twice a day. Treatment course will repeat every 28 days in the absence of disease progression or unacceptable toxicity

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

National Neuroscience Institute, Singapore, Singapore

Status

Address

National Neuroscience Institute

Singapore, ,

Site Contact

Dr Lin Xuling

[email protected]

+6563577171

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