Advanced Solid TumorPhase 1NCT06302426
Trial of INI-4001 in Patients With Advanced Solid Tumours
A Phase 1 study testing INI-4001, Nivolumab and Pembrolizumab in people with Advanced Solid Tumor, run by Inimmune Corporation at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- INI-4001, Nivolumab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesAustralia
- Study dates
- 1 Jul 2024to 19 Jun 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 steroids are allowed.
- History of prior organ allograft.
- Known hypersensitivity to the study drug or its inactive ingredients.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
The Border Cancer Hospital
Albury, New South Wales, 2640
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Cabrini Hospital
Malvern, Victoria, 3144
About this study
Official title: An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours
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.
Read the detailed description
This is a Phase Ia/Ib, open-label, dose-escalation, and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). Phase Ia will initially seek to establish the MTD of INI-4001 administered as a monotherapy. Following identification of the MTD, any dose level at or below the MTD may be further expanded to further explore the safety, PK, PD, and preliminary efficacy of INI-4001 alone and in combination with a complementary therapy (Phase Ib).
Following cessation of INI-4001, patients will be requested to participate in long-term follow-up to assess overall survival. This long-term follow-up will continue for each patient until at least 1 year after their last dose of INI-4001, or until otherwise advised by the Sponsor.
- Conditions
- Advanced Solid Tumor
- Being tested
- INI-4001, Nivolumab, Pembrolizumab, Cemiplimab, Avelumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INI-4001Drug
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.
NivolumabCombination product
Also called Opdivo
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.
PembrolizumabCombination product
Also called Keytruda
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.
CemiplimabCombination product
Also called Libtayo
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.
AvelumabCombination product
Also called Bavencio
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.
AtezolizumabCombination product
Also called Tecentriq
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.
DurvalumabCombination product
Also called Imfinzi
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.
| Study group | Role | What they receive |
|---|---|---|
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
| INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6 | Experimental | For 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. Receives: Drug: INI-4001; Combination Product: Nivolumab; Combination Product: Pembrolizumab; Combination Product: Cemiplimab; Combination Product: Avelumab; Combination Product: Atezolizumab; Combination Product: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Graded using a 5 point scale
Measured: 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
Graded using a 5 point scale
Measured: 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
Pulse rate [PR], systolic and diastolic blood pressure [BP], temperature, respiratory rate.[RR] and oxygen saturation.
Blood pressure will be measured using a sphygmomanometer, body temperature will be measured using a thermometer, Heart rate (HR) is measured using vital sign machine,respiratory rate is measured manually via 60- second count.[RR] and oxygen saturation is measured using a Oximeter. All abnormal assessments measured as Clinically significant post dose will be recorded as AEs.
Measured: 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
Weight will be measured utilising scales
Measured: 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
Haematology - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: 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
Number of Participants with a Change from baseline in clinical laboratory parameters (serum chemistry) after multiple ascending doses
Serum Chemistry - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: 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
Number of Participants with a Change from baseline in clinical laboratory parameters (urinalysis) after multiple ascending doses
Urinalysis - urine samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
Measured: 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
Change from baseline in measurements of HR in beats per minute after multiple ascending doses
12-lead ECG parameters include the measurements of HR in beats per minute. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in measurements of PR interval via 12-lead electrocardiogram after multiple ascending doses
12-lead ECG parameters include the measurements of PR interval. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in measurements of QT interval via 12-lead electrocardiogram after multiple ascending doses
12-lead ECG parameters include the . 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in measurements of RR interval in breaths per minute via 12-lead electrocardiogram after multiple ascending doses
12-lead ECG parameters include the measurements of RR interval in breaths per minute. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in measurements of QRS duration via 12-lead electrocardiogram after multiple ascending doses
12-lead ECG parameters include the measurements of QRS duration. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in measurements of QTcF via 12-lead electrocardiogram after multiple ascending doses
12-lead ECG parameters include the measurements of QTcF. 12-lead ECG will be taken in triplicate at screening and prior to infusion and as single measurements at all other timepoints.
Measured: Assessed at Screening, then Cycle 1 Day 1 through to Day 16 and then at 7 days and 30 days post last dose of INI-4001
Change from baseline in Eastern Cooperative Oncology Group (ECOG) score after multiple ascending doses
Graded using a 6 point scale
Measured: Screening, then Cycle 1 & Cycle 2 (each cycle is 21 days) on Day 1, Day 8 and Day 15 and then at 7 days and 30 days post last dose of INI-4001
Single dose PK Parameters - maximum observed concentration (Cmax)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - maximum observed concentration (Cmax)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Time to Cmax (Tmax)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - Time to Cmax (Tmax)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Total amount excreted in urine (Ae)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
Measured: Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)
Single dose PK Parameters - Fraction excreted in the urine (Fe)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
Measured: Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)
Single dose PK Parameters - Renal clearance (CLr)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
Measured: Cycle 1 Day 1 pre-dose, then 0-2, 2-4 and 4-6 hours post-dose, Day 1 to Day 2 6-24 hours post-dose (each cycle is 21 days)
Multiple dose PK Parameters - Area under the concentration-time curve from time 0 to 24 hours post-dose (AUC0-24)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Area under the concentration-time curve (AUC0-t)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - Area under the concentration-time curve (AUC0-t)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Half-life (t1/2)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - Half-life (t1/2)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Clearance (Cl)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - Clearance (Cl)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Single dose PK Parameters - Volume of distribution (Vz)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Multiple dose PK Parameters - Volume of distribution (Vz)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
Measured: Cycle 1 Day 1 & Day 15, pre-dose, EOI (within 2 minutes), then 15 & 30 minutes, 1, 2, 4 & 6 hours post-dose, Day 2 & Day 16 at 24 hours post-dose, Cycle 2 & 4 Day 1 pre-dose, EOI, Day 8 pre-dose then 7 days post last infusion (a cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Jul 2024
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a Phase Ia/Ib, open-label, dose-escalation and dose expansion study. This study will be conducted in two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inimmune Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Jon L Ruckle, Study director, Inimmune Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302426
- Sponsor's protocol ID
- INI-4001-101
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No