INI-4001 for advanced solid tumors

An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours

This Phase 1 test will try INI-4001 alone and with approved checkpoint inhibitors to see if it is safe and shows early benefit for adults with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inimmune Corporation (industry)
• Drugs / interventions: radiation, prednisone
• Locations: 3 sites (Albury, New South Wales and 2 other locations)
• Trial ID: NCT06302426 on ClinicalTrials.gov

What this trial studies

This Phase Ia/Ib open-label study uses dose-escalation followed by dose-expansion to find the maximum tolerated dose (MTD) of INI-4001 as a single agent and to explore selected doses alone and combined with approved checkpoint inhibitors. Phase Ia will escalate doses to establish safety, pharmacokinetics (PK), and pharmacodynamics (PD) and identify the MTD, while Phase Ib will expand cohorts at or below the MTD to gather additional safety and preliminary efficacy data. The study enrolls patients with measurable extracranial advanced or metastatic solid tumors and allows treated, stable brain metastases under specific conditions. After stopping INI-4001, patients are asked to join long-term follow-up for survival for at least one year.

Who should consider this trial

Good fit: Adults with measurable, locally advanced or metastatic extracranial solid tumors who are medically stable and meet the brain metastasis stability criteria are the intended candidates.

Not a fit: Patients with untreated primary brain/CNS tumors, uncontrolled spinal cord compression, or who cannot stop steroids or tolerate immunotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, INI-4001 could offer a new treatment option that slows tumor progression or increases responses when combined with checkpoint inhibitors.

How similar studies have performed: Other early-phase programs combining novel agents with checkpoint inhibitors have shown promise in some cancers, but INI-4001 itself remains early-stage and not yet proven in humans.

Eligibility criteria

Inclusion Criteria:

1. Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression)
2. Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria.
3. Patients with known brain metastases are eligible if they meet all the following criteria:

   1. 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 least 4 weeks before the first dose of study treatment)
   2. Patient is neurologically stable and has had no persistent side effects / complications from prior treatment.
   3. 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.
4. Female patients must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal

Exclusion Criteria:

1. Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor.
2. Has primary brain/CNS tumour or untreated spinal cord compression.
3. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis.
4. Evidence of abnormal cardiac function
5. 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.
6. 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.
7. History of other malignancy not meeting inclusion criterion #1 within the past 2 years
8. Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Day 1.
9. Received cancer-directed therapy
10. A history of autoimmune diseases that has caused terminal organ damage or required systemic immunosuppression / systemic disease modulating drugs within the past 2 years.
11. 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 steroids are allowed.
12. History of prior organ allograft.
13. Known hypersensitivity to the study drug or its inactive ingredients.

Where this trial is running

Albury, New South Wales and 2 other locations

• The Border Cancer Hospital — Albury, New South Wales, Australia (RECRUITING)
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (RECRUITING)
• Cabrini Hospital — Malvern, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Paul Wabnitz, Dr

Conditions: Advanced Solid Tumor