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New Dual-Antibody combo tackles multiple advanced cancers in early trial

NCT ID NCT05858736

First seen Apr 10, 2026 · Last updated Jun 23, 2026 · Updated 9 times

Summary

This early-stage trial is testing 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 various advanced solid tumors that have spread or come back. The main goals are to find a safe dose and watch for side effects, with early signs of tumor shrinkage also being tracked.

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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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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

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 antibodies: anti-PD-1 and anti-CTLA-4)

What this could lead to

If it works, this could point toward a new treatment option for several advanced cancers that have stopped responding to other therapies.

What could go wrong

This is a very early, small Phase 1 trial with only 18 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause significant side effects like immune-related inflammation.

Conditions

The condition(s) this trial relates to.

anus neoplasm bile duct neoplasm colorectal neoplasm endometrium neoplasm Esophageal Neoplasms fallopian tube neoplasm gastric neoplasm gastroesophageal cancer hepatocellular carcinoma melanoma non-small cell lung carcinoma renal cell carcinoma Squamous Cell Carcinoma of Head and Neck Urinary Bladder Neoplasms Uterine Cervical Neoplasms

As listed by the trial registrant

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