Actively Recruiting
Trial of INI-4001 in Patients With Advanced Solid Tumours
Led by Inimmune Corporation · Updated on 2026-01-16
50
Participants Needed
3
Research Sites
143 weeks
Total Duration
On this page
Sponsors
I
Inimmune Corporation
Lead Sponsor
A
Avance Clinical Pty Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of INI-4001 in Patients With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 have received definitive treatment with stable lesions for at least 4 weeks, are neurologically stable, and have not needed steroids for at least 14 days prior to treatment
- Female patients must be of non-child-bearing potential, either surgically sterilised at least 6 weeks before screening or postmenopausal
You will not qualify if you...
- Prior therapy with a TLR7 and/or TLR8 agonist, unless approved by the medical monitor
- Primary brain/CNS tumour or untreated spinal cord compression
- Known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis
- Evidence of abnormal cardiac function
- Clinically significant active infection within 2 weeks before treatment or fever above 38.1°C within 7 days before first dose
- Known active HIV-1 or HIV-2, hepatitis B surface antigen, or hepatitis C virus antibodies at screening
- History of another malignancy not meeting inclusion criteria within past 2 years
- Major surgery within 28 days or minor surgical procedures within 7 days before treatment
- Recent cancer-directed therapy
- History of autoimmune diseases causing terminal organ damage or requiring systemic immunosuppression within past 2 years
- Chronic use of immune-suppressive drugs exceeding 10 mg prednisone daily equivalent (inhaled steroids allowed)
- History of prior organ transplant
- Known hypersensitivity to the study drug or its inactive ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Border Cancer Hospital
Albury, New South Wales, Australia, 2640
Actively Recruiting
2
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
3
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Actively Recruiting
Research Team
P
Paul Wabnitz, Dr
CONTACT
L
Lucinda Tennant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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