Trial of INI-4001 in Patients With Advanced Solid Tumours

March 4, 2024 updated by: Inimmune Corporation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
        • Contact:
        • Principal Investigator:
          • Prachi Bhave, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi
Experimental: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
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.
Drug: INI-4001
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.
Combination product: Nivolumab
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.
Other Names:
  • Opdivo
Combination product: Pembrolizumab
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.
Other Names:
  • Keytruda
Combination product: Cemiplimab
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.
Other Names:
  • Libtayo
Combination product: Avelumab
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.
Other Names:
  • Bavencio
Combination product: Atezolizumab
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.
Other Names:
  • Tecentriq
Combination product: Durvalumab
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.
Other Names:
  • Imfinzi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 to determine the maximum tolerated dose of INI-4001 Monotherapy
Time Frame: Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21
Graded using a 5 point scale
Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, type, and severity of treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment after multiple ascending doses
Time Frame: Assessed at Screening, then daily from Cycle 1 Day 1 through to 30 days post last dose of INI-4001
Graded using a 5 point scale
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
Time Frame: Assessed from Cycle 1 Day 1 through to Cycle 1 Day 21
Graded using a 5 point scale
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
Time Frame: Assessed at Screening, then Cycle 1 Day 1 through to 30 days post last dose of INI-4001

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.
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
Time Frame: 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
Weight will be measured utilising scales
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
Time Frame: 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
Haematology - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
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
Time Frame: 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
Serum Chemistry - blood samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
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
Time Frame: 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
Urinalysis - urine samples will be collected. All safety laboratory assessments will be assessed by a local laboratory according to their reference ranges.
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
Time Frame: 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
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.
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
Time Frame: 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
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.
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
Time Frame: 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
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.
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
Time Frame: 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
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.
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
Time Frame: 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
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.
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
Time Frame: 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
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.
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
Time Frame: 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
Graded using a 6 point scale
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in urine following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following a single dose
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)
Time Frame: 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)
Pharmacokinetics (PK) of INI-4001 in blood plasma following multiple doses
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inimmune Corporation

Collaborators

Avance Clinical Pty Ltd.

Investigators

  • Study Director: Jon L Ruckle, Inimmune Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 29, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INI-4001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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