New combo immunotherapy drug enters human trials for 18 cancers

NCT ID NCT05858736

Ongoing Disease control Sponsor: OncoC4, Inc. Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ANAL CANCER are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

ANAL CANCER BILE DUCT CANCER BLADDER CANCER CERVICAL CANCER COLORECTAL CANCER ENDOMETRIAL CANCER ESOPHAGEAL CANCER FALLOPIAN TUBE CANCER GASTRIC CANCER GASTROESOPHAGEAL JUNCTION CANCER HEAD AND NECK SQUAMOUS CELL CARCINOMA HEPATOCELLULAR CARCINOMA HIGH GRADE SEROUS ADENOCARCINOMA OF OVARY MELANOMA NON-SMALL CELL LUNG CANCER PRIMARY PERITONEAL CARCINOMA RENAL CELL CARCINOMA

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.