NCT06302426

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Inimmune Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
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.
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.
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.
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.
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.
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-10-30
• Completion: 2027-03-30
• First posted: 2024-03-08
• Last updated: 2026-01-16

Locations

3 sites across 1 country: Australia