New combo immunotherapy drug enters human trials for 18 cancers

NCT ID NCT05858736

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called AI-061, which combines two immune-boosting antibodies (anti-PD-1 and anti-CTLA-4) into one treatment. The study will enroll 18 adults with advanced solid tumors that have spread or cannot be removed. The main goals are to find a safe dose and check for side effects, not yet to prove the drug works against cancer.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

AI-061 (a combination of two immunotherapy antibodies: anti-PD-1 and anti-CTLA-4)

What this could lead to

If this trial succeeds, it could point toward a new treatment option for several advanced solid tumors by boosting the immune system to fight cancer.

What could go wrong

This is a very early, small Phase 1 study with only 18 participants, focused on safety and dosing. It is not designed to prove the drug works, and side effects from immune activation can be serious.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

anal carcinoma anus neoplasm bile duct cancer bile duct neoplasm cervical cancer colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm esophageal cancer Esophageal Neoplasms fallopian tube cancer fallopian tube neoplasm gastric cancer gastric neoplasm gastroesophageal cancer head and neck squamous cell carcinoma hepatocellular carcinoma melanoma non-small cell lung carcinoma primary peritoneal carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck urinary bladder carcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cancer Research SA

    Adelaide, South Australia, 5000, Australia

  • Mater Misericordiae Ltd.

    Brisbane, Queensland, 4006, Australia

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 5042, Australia

  • St. Vincent's Private Hospital

    Darlinghurst, New South Wales, 2010, Australia

  • Tasman Oncology Research

    Southport, Queensland, 4120, Australia