Table of Contents
- Trial overview
- Who the trials are for
- Study design and treatment groups
- What the trials measure
- Main trial goals and what they mean
- Trial status and size
Trial overview
The clinical trials in the source data are studying Ict01 in people with serious cancers, especially advanced disease that has come back or has not responded to treatment.[1] Both studies are Phase 1/2 trials, which means they first focus on safety and then look for early signs that the treatment may help control cancer.[1][1]
One trial is described as a first-in-human study in patients with advanced-stage, relapsed/refractory cancer.[1] The other trial studies intravenous Ict01 in advanced solid tumors, including several metastatic cancers.[1]
Who the trials are for
The patient groups in these studies include people with advanced-stage, relapsed/refractory cancer, which means cancer that is advanced and has either returned after treatment or did not respond well to treatment.[1] The source data also includes patients with newly diagnosed acute myeloid leukemia (AML), a fast-growing blood cancer.[1]
Another study includes people with metastatic or unresectable refractory melanoma, metastatic ovarian cancer, metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and metastatic castration-resistant prostate cancer.[1] These are all advanced cancers, and some have spread to other parts of the body.[1]
Study design and treatment groups
Both studies are interventional, which means the researchers give a treatment and then observe what happens.[1][1] The studies use intravenous treatment, meaning the medicine is given through a vein.[1][1]
In the first study, Ict01 is studied as monotherapy, meaning by itself, and also in combination with pembrolizumab (Keytruda).[1] The brief summary also states that part of the study looks at Ict01 combined with venetoclax and azacitidine in newly diagnosed AML.[1]
In the second study, Ict01 is studied with low-dose subcutaneous interleukin-2, and some parts also include pembrolizumab for selected advanced solid tumors.[1] The study is open-label, which means both the research team and the participants know which treatment is being given.[1]
What the trials measure
The main safety measures include the incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events that lead to stopping or changing treatment.[1][1] The studies also check laboratory abnormalities, vital signs, ECGs, and physical examination findings.[1][1]
In the first trial, the cancer response part includes disease control rate (DCR) for solid tumors and complete remission rate for AML, using standard cancer assessment rules.[1] The continued treatment period measures duration of response, which means how long the benefit lasts after a response is seen.[1]
In the second trial, the main activity endpoint is disease control rate, which includes stable disease, partial response, and complete response according to RECIST.[1] RECIST is a standard method used to measure how tumors change on scans during treatment.[1]
Main trial goals and what they mean
The first study aims to understand the safety and tolerability of Ict01 in people with relapsed or refractory advanced cancers, both alone and in combination with other treatments.[1] It also looks for early signs that the treatment may help patients with advanced solid tumors or AML.[1]
The second study aims to describe the safety and tolerability of Ict01 with low-dose interleukin-2, and in some cases with pembrolizumab, in advanced solid tumors.[1] It also looks at preliminary anti-tumor activity, which means early evidence that the treatment may slow or control the cancer.[1]
Trial status and size
The first trial is listed as Authorised and has an enrollment of 375 participants.[1] The second trial is listed as Completed and enrolled 88 participants.[1]
These studies give an early picture of how Ict01 is being tested in different cancer groups, but they do not yet show final treatment benefit from the source data alone.[1][1]
