RecruitingPhase 1NCT05627960

First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma

Sponsor

A&G Pharmaceutical Inc.

Enrollment

77 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer Non-small Cell Lung Cancer Mesothelioma Hormone-Resistant Breast Cancer

Summary

This is a first in human phase 1 study of AG01 an anti-Progranulin/Glycoprotein88 (PGRN/GP88) antibody in patients with advanced solid tumors. AG01 is a recombinant monoclonal antibody expressed in a CHO production cell line. The antibody AG01 binds to human PGRN/GP88, expressed on cancer cells. This study will have a dose escalation portion (1A) to evaluate maximum tolerated dose (MTD) and/or maximum administered dose (MAD), the safety and tolerability of AG01treatment before the dose expansion portion (1B) of the study is initiated. The dose escalation portion of this study (1A) will also be used to determine the recommended phase 2 dose (RP2D) of AG01 antibody to be evaluated in the cohort expansion portion (1B).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new antibody drug called AG01, which targets a protein called progranulin/GP88 that helps some cancers grow. It is being tested in people with advanced solid tumors (various cancers) that have already progressed on standard treatments. The main goals are to determine a safe dose and check for early signs of effectiveness. **You may be eligible if...** - You are 18 or older with an advanced cancer confirmed by biopsy or cytology - Your cancer has at least one measurable metastatic lesion - You have already tried and failed one or more standard treatments - Your general performance status is reasonable (ECOG ≤2) - Your liver, kidneys, and blood counts meet minimum thresholds - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have received chemotherapy or radiation within 4 weeks (or 6 weeks for certain drugs) - You have another active serious condition that could compromise safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAG-01 Compound

Phase 1A dose escalation study: enrolled subjects with advanced solid tumors will receive AG-01 compound at various doses. Phase 1B patients will be treated with AG-01 at the RP2D.