Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05627960

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

Led by A&G Pharmaceutical Inc. · Updated on 2022-11-28

77

Participants Needed

1

Research Sites

245 weeks

Total Duration

On this page

Sponsors

A

A&G Pharmaceutical Inc.

Lead Sponsor

U

University of Maryland Greenebaum Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any study procedures
  • 18 years of age or older
  • Histologic or cytologic diagnosis of advanced cancer
  • Radiographic evidence of at least 1 measurable metastatic lesion per RECIST 1.1 criteria
  • Relapsed/refractory solid tumor patients who failed one or more standard chemotherapy or targeted therapy per SOC guidelines (Phase 1A)
  • GP88 tissue tumor expression of 1+, 2+ or 3+ by IHC for Phase 1B patients (archival or biopsy tissue)
  • At least 4 weeks since last chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin
  • ECOG performance status 0 to 2
  • Adequate liver, kidney, and bone marrow function as defined by study
  • Use of highly effective contraception during study and for 90 days after
  • Negative pregnancy test for females of reproductive age
  • Life expectancy greater than 12 weeks
  • Specific prior therapies required for certain cancer cohorts as detailed in the protocol
Not Eligible

You will not qualify if you...

  • Uncontrolled illnesses including serious heart conditions or psychiatric illness affecting compliance
  • Untreated or unstable central nervous system metastases (treated CNS metastases allowed if stable)
  • Carcinomatous meningeal involvement
  • Participation in another investigational drug study within 28 days before this study
  • Pregnant or breastfeeding females
  • Inability to use or comply with effective contraception
  • History of other cancers within the last 2 years except certain in-situ or treated skin cancers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

Loading map...

Research Team

G

Ginette Serrero, PhD/DSC.

CONTACT

K

Katherine Tkaczuk, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here