Trial Title:
Trial of INI-4001 in Patients With Advanced Solid Tumours
NCT ID:
NCT06302426
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Pembrolizumab
Nivolumab
Atezolizumab
Durvalumab
Avelumab
Cemiplimab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention 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).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INI-4001
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Intervention type:
Combination Product
Intervention name:
Nivolumab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Opdivo
Intervention type:
Combination Product
Intervention name:
Pembrolizumab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Keytruda
Intervention type:
Combination Product
Intervention name:
Cemiplimab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Libtayo
Intervention type:
Combination Product
Intervention name:
Avelumab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Bavencio
Intervention type:
Combination Product
Intervention name:
Atezolizumab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Tecentriq
Intervention type:
Combination Product
Intervention name:
Durvalumab
Description:
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.
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
Arm group label:
INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
Other name:
Imfinzi
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Border Cancer Hospital
Address:
City:
Albury
Zip:
2640
Country:
Australia
Contact:
Last name:
Reenu Arora
Email:
AroraReenu@ramsayhealth.com.au
Investigator:
Last name:
Kay Xu, Dr
Email:
Principal Investigator
Facility:
Name:
Cabrini Hospital
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Contact:
Last name:
Prachi Bhave
Email:
PBhave@cabrini.com.au
Investigator:
Last name:
Prachi Bhave, Dr
Email:
Principal Investigator
Start date:
March 29, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Inimmune Corporation
Agency class:
Industry
Collaborator:
Agency:
Avance Clinical Pty Ltd.
Agency class:
Industry
Source:
Inimmune Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302426