Trial of INI-4001 in Patients With Advanced Solid Tumours

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06302426
Study type	Interventional
Source	Inimmune Corporation
Contact	Paul Wabnitz, Dr
Phone	+61 448665638
Email	paul.wabnitz@clinpharma.com.au
Status	Not yet recruiting
Phase	Phase 1
Start date	March 29, 2024
Completion date	April 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06223308` - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT05508100` - Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors	Phase 1
Not yet recruiting	`NCT05515185` - B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors	Early Phase 1
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT02836600` - A Study of LY3039478 in Japanese Participants With Advanced Solid Tumors	Phase 1
Recruiting	`NCT04890613` - Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation	Phase 1
Recruiting	`NCT04390737` - Evaluate the Safety and Clinical Activity of HH2853	Phase 1/Phase 2
Recruiting	`NCT06007482` - A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1
Recruiting	`NCT05981703` - A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors	Phase 1
Completed	`NCT04108676` - Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects	Phase 1
Recruiting	`NCT05798611` - Study of ART0380 in Patients With Biologically Selected Solid Tumors	Phase 2
Recruiting	`NCT05076396` - PM14 Administered Intravenously to Patients With Advanced Solid Tumors	Phase 1
Recruiting	`NCT06054932` - Safety, Tolerability, and Immunogenicity of LK101 Alone in Participants With Incurable Solid Tumors	Phase 1
Recruiting	`NCT06008366` - A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04825392` - A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors	Phase 1
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Not yet recruiting	`NCT06365918` - Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis	Phase 1
Recruiting	`NCT05569057` - A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma	Phase 1
Recruiting	`NCT05443126` - A Study of EP0031 in Patients With Advanced RET-altered Malignancies	Phase 1/Phase 2
Recruiting	`NCT05461287` - Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors	Phase 1