RecruitingPhase 1NCT06302426

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

Sponsor

Inimmune Corporation

Enrollment

50 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria13

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.
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.

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Interventions

DRUGINI-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_PRODUCTNivolumab

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.

COMBINATION_PRODUCTPembrolizumab