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NCT05627960 · ClinicalTrials.gov registry record · Phase 1
First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
A Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by A&G Pharmaceutical.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT05627960 is a Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by A&G Pharmaceutical. The registered enrollment target is 77 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05627960, a Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by A&G Pharmaceutical.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG AG-01 Compound
Study Locations (1)
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05627960
The ClinicalTrials.gov registry entry for NCT05627960 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The listed sponsor is A&G Pharmaceutical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which AG-01 Compound is the first listed.
NCT05627960 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05627960 about?
NCT05627960 is a clinical study titled "First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies". 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. Th...
What is the current status of trial NCT05627960?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2022-02-14. Estimated completion is 2026-11.
What conditions does trial NCT05627960 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Mesothelioma, Hormone-Resistant Breast Cancer.
What interventions are being tested in trial NCT05627960?
The interventions under investigation include: AG-01 Compound (DRUG).
Who is sponsoring clinical trial NCT05627960?
This trial is sponsored by A&G Pharmaceutical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05627960 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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