Table of contents
- Overview of the trials
- Who the trials include
- How the studies are designed
- What the trials measure
- Treatment combinations being tested
- Main points for patients
Overview of the trials
The available data describe two interventional studies of Ict01 in cancer, both in Phase 1/2.[1][1] One study is a first-in-human trial in patients with advanced-stage, relapsed/refractory cancer, and it is authorised.[1] The other study is an open-label trial in advanced solid tumors and is completed.[1]
Who the trials include
The first study includes patients with advanced-stage, relapsed/refractory cancer, which means cancer that is late stage and has come back or does not respond to treatment.[1] The second study includes people with advanced solid tumors, with specific cancer types listed as metastatic castration-resistant prostate cancer, metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, metastatic or unresectable refractory melanoma, and metastatic ovarian cancer.[1]
In the first study, the brief summary also mentions patients with relapsed/refractory advanced solid tumors or hematologic malignancies, and a part of the study focuses on newly diagnosed acute myeloid leukemia (AML).[1] In the second study, the trial also includes advanced melanoma or pancreatic ductal adenocarcinoma in a part that combines Ict01 with low-dose subcutaneous interleukin-2 and pembrolizumab.[1]
How the studies are designed
Both trials are interventional, which means the researchers give treatment and then measure the results.[1][1] The first study is a first-in-human design, so it is the first time the treatment is being tested in people in this setting.[1] The second study is open-label, meaning both the study team and the participants know which treatment is being used.[1]
The first trial has an enrollment of 375, and the second trial has an enrollment of 88.[1][1] In the first study, Ict01 is given intravenously, meaning through a vein.[1] In the second study, Ict01 is also given intravenously, and the study explores different combinations across its parts.[1]
What the trials measure
The first study mainly measures safety and tolerability by looking at treatment-emergent adverse events, serious adverse events, and treatment changes caused by side effects or other problems.[1] It also checks laboratory test abnormalities, vital signs, electrocardiograms, and physical examination findings.[1] These are standard ways to see whether the treatment causes medical problems during the study.[1]
In the first study, later parts also measure disease control rate for solid tumors and complete remission rate for AML.[1] Disease control rate includes complete response, partial response, and stable disease according to RECIST 1.1, a standard method used to measure tumor change on scans.[1] For AML, the study uses ELN 2022 criteria and measures complete remission, complete remission with partial hematologic recovery, complete remission with incomplete hematologic recovery, and morphologic leukemia-free state.[1]
The second study also focuses first on safety and tolerability, including dose-limiting toxicities, treatment-emergent adverse events, fatal adverse events, serious treatment-emergent adverse events, and treatment modifications or discontinuation.[1] It additionally measures clinically significant laboratory, vital sign, ECG, and physical examination findings.[1] Its main activity outcome is disease control rate, defined as stable disease, partial response, or complete response per RECIST.[1]
Treatment combinations being tested
The first study tests Ict01 as monotherapy, which means alone, and also in combination with pembrolizumab, known in the trial as Keytruda.[1] It also includes a continued treatment period to assess how long the benefit lasts in people who still have clinical benefit.[1]
The second study tests Ict01 with low-dose subcutaneous interleukin-2, also called LDSC IL-2, and in some parts with pembrolizumab.[1] The brief summary also mentions combinations with venetoclax and azacitidine in newly diagnosed AML in the first study record.[1] These combinations are being explored to see whether they improve early anti-tumor activity.[1][1]
Main points for patients
These trials are early cancer studies, not routine treatment programs.[1][1] Their main goal is to learn whether Ict01 can be used safely and whether it shows signs of helping against cancer in advanced disease.[1][1]
The studies focus on patients with difficult-to-treat cancers, including advanced solid tumors and AML.[1][1] They use standard cancer research measures such as adverse events, RECIST, disease control rate, and remission criteria to judge the results.[1][1]
