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New treatment option for Advanced Solid Tumor
Official title Trial of INI-4001 in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT06302426
What this study is testing
What is INI-4001?
INI-4001 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression)
- Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria.
- Patients with known brain metastases are eligible if they meet all the following criteria:
- Patient has received definitive treatment of brain metastases with stereotactic body radiation therapy (SBRT) or surgery provided that the brain...
- Patient is neurologically stable and has had no persistent side effects / complications from prior treatment.
You likely can't join if
- Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor.
- Has primary brain/CNS tumour or untreated spinal cord compression.
- Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
- Evidence of abnormal cardiac function
- Clinically significant active infection within 2 weeks prior to commencement of treatment, or unexplained fever (temperature \> 38.1°C) within 7 days...
- Known active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the...
See the full eligibility criteria
- Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression)
- Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria.
- Patients with known brain metastases are eligible if they meet all the following criteria:
- Patient has received definitive treatment of brain metastases with stereotactic body radiation therapy (SBRT) or surgery provided that the brain lesions are stable (without evidence of progression by imaging for at...
- Patient is neurologically stable and has had no persistent side effects / complications from prior treatment.
- Patient has no evidence of new or enlarging brain metastases (confirmed by repeat imaging) and has not required steroids for at least 14 days prior to first dose administration on Day 1.
- Female patients must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal
- Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor.
- Has primary brain/CNS tumour or untreated spinal cord compression.
- Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
- Evidence of abnormal cardiac function
- Clinically significant active infection within 2 weeks prior to commencement of treatment, or unexplained fever (temperature \> 38.1°C) within 7 days prior to first dose administration on Cycle 1 Day 1.
- Known active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- History of other malignancy not meeting inclusion criterion #1 within the past 2 years
- Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Day 1.
- Received cancer-directed therapy
- A history of autoimmune diseases that has caused terminal organ damage or required systemic immunosuppression / systemic disease modulating drugs within the past 2 years.
- Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, (e.g., COPD) in dosing exceeding 10 mg daily of prednisone equivalent). Inhaled...
- History of prior organ allograft.
- Known hypersensitivity to the study drug or its inactive ingredients.
The study team makes the final eligibility decision.
Where it's taking place
- Albury, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Malvern, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albury, New South Wales, Australia; Bedford Park, South Australia, Australia; Malvern, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.