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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

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