New drug aims to supercharge immune system against Hard-to-Treat cancers
NCT ID NCT06302426
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new drug called INI-4001, which is designed to activate the immune system to fight advanced solid tumors. About 50 adults with cancers that have spread or cannot be removed will receive the drug alone or combined with standard immunotherapy drugs like nivolumab or pembrolizumab. The main goal is to find the safest dose and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only โ not medical advice or a prediction.
- Active substance
- INI-4001 (a drug that activates the immune system to attack tumors), given alone or with nivolumab or pembrolizumab
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors by boosting the body's immune response.
- What could go wrong
- This is a very early Phase 1 trial with only 50 people, so it may not work or could have side effects. The main goal is just to find a safe dose, not to prove effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cabrini Hospital
RECRUITINGMalvern, Victoria, 3144, Australia
-
Southern Oncology Clinical Research Unit
RECRUITINGBedford Park, South Australia, 5042, Australia
-
The Border Cancer Hospital
RECRUITINGAlbury, New South Wales, 2640, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can your own immune cells beat advanced cancer?
- Tumor DNA mapping may unlock personalized cancer therapies
- Can a new drug combo shrink Hard-to-Treat tumors?
- Can a protein calm the immune System's overreaction to cancer treatment?
- Can a new drug shrink Hard-to-Treat tumors?
- Can a Custom-Made immune cell vaccine turn the tide against solid tumors?