Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
INI-4001-101
Clinical summary
Summary
This study will be conducted in two parts: Phase 1a (dose escalation) and Phase 1b (dose expansion).
Phase 1a will initially seek to establish the maximum tolerated dose (MTD) of a medicine called INI-4001 when given by itself. Following the identification of the MTD, any dose level at or below the MTD may be further expanded to further explore the safety and effectiveness of INI-4001 alone, and in combination with complementary treatments (Phase 1b).
One participants have stopped taking INI-4001, they will be requested to participate in long-term follow-up to continue assessing the effectivness of INI-4001 on overall survivall. Long-term follow-up will continue for each participant until at least 1 year after their last dose of INI-4001, or until otherwise advised by the study sponsor.
Conditions
This trial is treating people with locally advanced or metastatic solid cancers (excluding primary brain or central nervous system tumours)
Eligibility
Inclusion
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
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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Inimmune Corporation
Scientific Title
An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information