Phase 1 Study of AG01 for Advanced Solid Tumors
This is an early-stage study testing a new treatment called AG-01 for people with advanced solid tumors, including triple-negative breast cancer, hormone-resistant breast cancer, non-small cell lung cancer, and mesothelioma. AG-01 is a monoclonal antibody, a type of targeted therapy that works by binding to a protein called PGRN/GP88 found on cancer cells. The main goals are to find the safest dose of AG-01 and see if it can shrink tumors. You might be able to join if you are at least 18 years old, have advanced cancer that has spread, and have measurable tumors. The current recruitment status is unclear.
- Study design
- This is a Phase 1 study, which means it's one of the first times AG-01 is being tested in people. It plans to enroll 77 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Antitumor activity will be measured every 56 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katherine Tkaczuk, MD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
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What this trial measures
- Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD)28 days during 1st cycle
Determine the MTD and/or MAD of anti GP88 monoclonal antibody (AG-01) in subjects with advanced/refractory solid tumor malignancies for which no effective therapies exist.
- Antitumor Activity of AG-01 by Overall Response Rate (ORR)Every 56 Days
To evaluate the antitumor activity of AG-01 monoclonal antibody as assessed by ORR defined as complete response (CR), partial response (PR), stable disease \>24 weeks (SD) (CR+PR+ SD) based on RECIST v1.1 in subjects with TNBC, ER+ hormone resistant Breast Cancer, NSCLCA and mesothelioma. Each cohort will be assessed separately for response.