Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS

This clinical trial is investigating a new treatment approach for specific advanced cancers, including bowel cancer (colorectal cancer), a type of lung cancer (non-small cell lung cancer), and soft tissue sarcoma, which have not responded to standard chemotherapy or immunotherapy. The study involves a heat-based treatment called thermal ablation, followed by an injection of a new investigational drug called IP-001 directly into the tumour. The main goals are to find out if this combination is safe for patients and if it can help to control the cancer. This research could potentially offer a new way to treat these cancers when other options have been exhausted, providing hope for patients seeking further treatment avenues.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Immunophotonics, Inc.

Enrolment target

Start

29 Nov 2022

Estimated completion

01 Feb 2025

Metastatic Solid Tumor Colon Cancer Nonsmall Cell Lung Cancer Soft Tissue Sarcoma

What is this study about?

This study is looking at a new way to treat certain advanced cancers. These include bowel cancer (colorectal cancer), a common type of lung cancer (non-small cell lung cancer), and cancers that develop in soft tissues like muscle or fat (soft tissue sarcoma). Patients joining this trial will have already tried standard treatments like chemotherapy or immunotherapy, but their cancer hasn't fully responded, or they can't have those treatments anymore.

The main idea behind this study is to directly target the cancer cells. It involves a two-step process. First, a treatment called thermal ablation uses heat to destroy part of the tumour. Shortly after this, an experimental medicine called IP-001 is injected directly into the tumour area. Researchers want to understand if this combined approach is safe for patients and if it can effectively shrink or control the cancer.

By taking this approach, the hope is to find a new treatment option for patients who have limited choices left. This kind of research is crucial for developing new therapies that can improve the lives of people living with advanced cancer.

Key takeaways

This study is for certain advanced bowel, lung, or soft tissue sarcoma cancers.
It tests a new injection (IP-001) after a heat treatment (ablation) directly into the tumour.
It's for patients whose cancers haven't responded well to standard therapies.
The main goals are to check safety and if the treatment helps control the cancer.
Participation involves treatment over several months, followed by a monitoring period.
You have the right to stop participating at any time.

Who may be eligible?

To join this study, you would generally need to be an adult aged 18 or over. You should have been diagnosed with advanced bowel cancer, a type of lung cancer, or soft tissue sarcoma, and these cancers should not have responded well to at least one, but no more than four, previous lines of standard treatment. Your doctors would need to confirm that you’re well enough to participate, with important organs like your liver, kidneys, and bone marrow working adequately, and that you have a life expectancy of more than six months.

Crucially, you would need to have at least one tumour that can be reached and treated with the heat ablation method, and it must be at least 1 centimetre in size but not larger than 5 centimetres. Your cancer also needs to be measurable so doctors can properly track any changes during the study.

However, you wouldn't be able to join if you have allergies to shellfish or any ingredients in the study treatment. Also, if your cancer has spread to your brain or spinal fluid, or if you've recently had other cancer treatments like chemotherapy, radiotherapy, or immunotherapy within the last three weeks, you wouldn't be eligible. The team will carefully check all these details to make sure the study is safe and appropriate for you.

Quick self-check

Are you 18 years old or older?
Do you have advanced bowel, a type of lung, or soft tissue sarcoma cancer that hasn't responded to earlier treatments?
Do you have a tumour that can be treated with heat and is between 1 and 5 cm?
Are you generally well enough for the study, with your organs working properly?
Do you NOT have allergies to shellfish or ingredients in the study drug?
Have you NOT had other cancer treatments like chemotherapy or radiotherapy in the last 3 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part and are found to be suitable after an initial check-up period, you will enter the treatment phase. This involves having a routine heat treatment (radiofrequency ablation or RFA) to a specific tumour, followed by an injection of the study drug, IP-001, directly into that tumour. This treatment can be repeated every six weeks, for a maximum of four times.

Throughout the study, regular check-ups, including scans, will be carried out to monitor your health and how the treatment is affecting your cancer. Once you've completed all your treatments, or if it's decided that no more treatments are needed, you will move into a six-month follow-up period. During this time, you'll have follow-up visits every six weeks for a total of five visits. These visits are important to continue monitoring your health and the progress of your cancer, or until you start a new cancer treatment if needed.

Potential risks and benefits

Participating in this trial might offer a potential benefit by providing access to a new treatment approach when standard options haven't worked or are no longer suitable. This could potentially help control your cancer. However, as with any new treatment, there are potential risks, including side effects from the thermal ablation or the IP-001 injection, some of which might be severe or unexpected. The research team will explain all known risks and monitor you closely for any issues. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (16)

Miami Cardiac & Vascular Institute
Coral Gables, United States
University of Louisville Physicians, PSC
Louisville, United States
Stephenson Cancer Center
Oklahoma City, United States
Institut Bergonie
Bordeaux, France
Hospitalier Pitie-Salpetriere
Paris, France
Hôpital Foch
Suresnes, France
Institut Gustave Roussy
Villejuif, France
Johann Wolfgang Goethe-Univresitat Frankfurt/Main
Frankfurt, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, Germany
Munchen Klinik Bogenhausen
Munich, Germany
IOSI Ospedale San Giovanni Bellinzona
Bellinzona, Switzerland
Inselspital Universitatsspital, Bern
Bern, Switzerland

+4 more sites — see the official record for the full list.

Common questions

What is 'thermal ablation'?

Thermal ablation is a treatment that uses heat to destroy cancer cells. It's often used to treat smaller tumours.

What is IP-001?

IP-001 is an experimental drug being tested in this study. It's given as an injection directly into the tumour after the heat treatment, to see if it helps fight the cancer.

How long will the treatment phase last?

You could receive up to four treatments, with each one six weeks apart. So, the main treatment phase could last around 18 weeks (about 4.5 months).

What happens after the treatments?

After your treatments, there's a six-month follow-up period where you'll have frequent check-ups (every six weeks for five visits) to monitor your health and the cancer.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your medical care.