Solid Tumor, Adult Clinical Trial
Official title:
A Two-part, Open-label, Clinical Study to Assess the Safety, Tolerability and Activity of Intravenous Doses of ICT01 in Combination With Low-dose Subcutaneous Interleukin-2 in Patients With Advanced Solid Tumors (EVICTION-2)
This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors. Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2. Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04551885 -
FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05054348 -
First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06088004 -
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05055609 -
Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors
|
Phase 1 | |
| Completed |
NCT04020185 -
Safety and Efficacy Study of IMSA101 in Refractory Malignancies
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05071846 -
MVX-ONCO-2 in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05607199 -
A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
|
Phase 1 | |
| Active, not recruiting |
NCT04552288 -
Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
|
Phase 2 | |
| Active, not recruiting |
NCT06026254 -
A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial
|
Phase 1 | |
| Recruiting |
NCT06032845 -
Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Solid Tumors (CASTLE-11)
|
Phase 2 | |
| Recruiting |
NCT06144671 -
GT201 Injection For The Treatment Of Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06398418 -
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05276284 -
Thiopurine Enhanced Mutations for PD-1/Ligand-1 Efficacy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04121442 -
Isunakinra Alone and in Combination With a PD-1/PD-L1 Inhibitor in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04221204 -
A Monotherapy in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT03992326 -
Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
| Terminated |
NCT05435339 -
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04981119 -
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
|
||
| Recruiting |
NCT06075849 -
Phase I Study to Evaluate Safety and Anti-tumor Activity of PB101, an Anti-angiogenic Immunomodulating Agent
|
Phase 1 |