Clinical trial NCT06302426: Trial of INI-4001 in Patients With Advanced Solid Tumours
Official title: An Open-label, Multiple-Ascending Dose, Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours
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.
Interventions:
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.
name: INI-4001
type: Drug
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.
name: Nivolumab
other_name: Opdivo
type: Combination Product
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.
name: Pembrolizumab
other_name: Keytruda
type: Combination Product
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.
name: Cemiplimab
other_name: Libtayo
type: Combination Product
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.
name: Avelumab
other_name: Bavencio
type: Combination Product
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.
name: Atezolizumab
other_name: Tecentriq
type: Combination Product
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.
name: Durvalumab
other_name: Imfinzi
type: Combination Product
Study arms:
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 1
design_group_type: Experimental
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 2
design_group_type: Experimental
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 3
design_group_type: Experimental
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 4
design_group_type: Experimental
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 5
design_group_type: Experimental
design_group_description: 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.
design_group_title: INI-4001 Monotherapy Dose Escalation - INI-4001 Dose Level 6
design_group_type: Experimental
Sponsor: Inimmune Corp.
Collaborators: Avance Clinical Pty Ltd.
Drug name mappings:
name: INI-4001
lang: EN
name: 纳武利尤单抗
lang: CN
name: Nivolumab
lang: EN
name: ニボルマブ（遺伝子組換え）
lang: JP
name: 阿维单抗
lang: CN
name: Avelumab
lang: EN
name: アベルマブ（遺伝子組換え）
lang: JP
name: 塞普利单抗
lang: CN
name: Cemiplimab-RWLC
lang: EN
name: セミプリマブ（遺伝子組換え）
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 度伐利尤单抗
lang: CN
name: Durvalumab
lang: EN
name: デュルバルマブ（遺伝子組換え）
lang: JP