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Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

NCT05858736 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-09

No results posted yet for this study

Summary

AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody. This is a dose escalation study to identify the maximum toxicity dose (MTD) or the recommended phase 2 dose (RP2D).

Conditions

Interventions

DRUG

AI-061

A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.

Sponsors & Collaborators

  • OncoC4 AU Pty Ltd

    collaborator UNKNOWN

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • OncoC4, Inc.

    lead INDUSTRY

Principal Investigators

  • Rohit Joshi, MD · Cancer Research South Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858736 on ClinicalTrials.gov