Trial of INI-4001 in Patients With Advanced Solid Tumours
An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours
1 other identifier
interventional
50
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2024
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2027
January 16, 2026
May 1, 2025
2.3 years
January 16, 2024
January 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy
Graded using a 5 point scale
Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21
Secondary Outcomes (31)
Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses
Assessed at Screening, then daily from Cycle 1 Day 1 through to 30 days post last dose of INI-4001
Incidence and nature of dose-limiting toxicities (DLTs) and regimen-limiting toxicities (RLTs) leading to discontinuation of study treatment after multiple ascending doses
Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21
Number of Participants with a Change from baseline in Vital signs measurements after multiple ascending doses
Assessed at Screening, then Cycle 1 Day 1 through to 30 days post last dose of INI-4001
Number of Participants with a Change from baseline in body weight after multiple ascending doses
Assessed at Screening then pre-dose on Day 1 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first
Number of Participants with a Change from baseline in clinical laboratory parameters (haematology) after multiple ascending doses
Assessed at Screening, then Day 1 and Day 15 of each 21 day cycle, assessed for up to 36 months or until disease progression, which occurs first
- +26 more secondary outcomes
Study Arms (6)
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
EXPERIMENTALFor dose-level 1, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
EXPERIMENTALFor dose-level 2, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
EXPERIMENTALFor dose-level 3, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
EXPERIMENTALFor dose-level 4, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
EXPERIMENTALFor dose-level 5, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
EXPERIMENTALFor dose-level 6, INI-4001 will be administered intravenously once per week on Days 1, 8 and 15 of a 21-day cycle. A complementary therapy may be introduced in combination with INI-4001.
Interventions
INI-4001 is a small molecule TLR7/8 agonist being developed as a standalone treatment for the induction of anti-tumour immune responses and sensitization to immune checkpoint inhibitor (ICI) therapy.
During both Phase Ia and Phase Ib, patients may meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) may transition to combination therapy.
During both Phase Ia and Phase Ib, patients meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) transition to combination therapy.
During both Phase Ia and Phase Ib, patients meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) transition to combination therapy.
During both Phase Ia and Phase Ib, patients meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) transition to combination therapy.
During both Phase Ia and Phase Ib, patients meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) transition to combination therapy.
During both Phase Ia and Phase Ib, patients meeting required criteria (at the discretion of the PI in consultation with the study Sponsor) transition to combination therapy.
Eligibility Criteria
You may qualify 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 lesions are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment)
- 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
You may not qualify 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 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.
- 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 steroids are allowed.
- History of prior organ allograft.
- Known hypersensitivity to the study drug or its inactive ingredients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inimmune Corporationlead
- Avance Clinical Pty Ltd.collaborator
Study Sites (3)
The Border Cancer Hospital
Albury, New South Wales, 2640, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042, Australia
Cabrini Hospital
Malvern, Victoria, 3144, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jon L Ruckle
Inimmune Corp
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2024
First Posted
March 8, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
March 30, 2027
Last Updated
January 16, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share