Trial of INI-4001 in Patients With Advanced Solid Tumours

Sponsor
Inimmune Corporation
Study ID
NCT06302426
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INI-4001 — DRUG
    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.
  • Nivolumab — COMBINATION_PRODUCT
    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.
  • Pembrolizumab — COMBINATION_PRODUCT
    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.
  • Cemiplimab — COMBINATION_PRODUCT
    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.
  • Avelumab — COMBINATION_PRODUCT
    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.
  • Atezolizumab — COMBINATION_PRODUCT
    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.
  • Durvalumab — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
May 2025
Primary completion
Oct 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

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