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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by A&G Pharmaceutical.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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 |
What NCT05627960 shows while recruiting
NCT05627960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05627960's enrollment target sits among peer trials
77 273rd of 454 higher than 182 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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