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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
A&G Pharmaceutical Inc.
Study ID
NCT05627960
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AG-01 Compound — DRUG
    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.

Study Details

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).

Key Dates

Start date
Feb 14, 2022
Status verified
Nov 2022
Primary completion
Jun 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
77 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AG-01 treated group phase 1A
    For dose escalation, subjects will be treated with increasing doses of AG01 from 1 mg/kg to 8 mg/kg. The duration of each treatment cycle is 28 days with two infusions of AG01 every 14 days.
  • Experimental: AG-01 1B triple negative breast cancer treated group
    TNBC is defined as ER and/or PR \< 1% by IHC, HER2 \<3+ by IHC and/or FISH negative, subjects must have received 1 or more standard of care (SOC) therapies for metastatic TNBC. If PD(L)1-positive, must have received a combination of chemotherapy and a PD (L)-1 agent (Pembrolizumab), unless not a candidate for these therapies If gBRCA 1 or 2 mutation is present, must have received SOC therapies including a PARPi, unless not a candidate for these therapies. Sacituzumab Govitecan ADC is FDA approved for treatment of advanced TNBC, prior exposure to this therapy does not preclude eligibility in the current study.
  • Experimental: AG-01 1B Hormone-resistant breast cancer
    Hormone-resistant breast cancer is defined as, ER and/or PR \>1%, HER2 \<3+ by IHC and/or FISH negative, received 1 or more hormonal (HT) therapies or HT/CD4/6 kinase inhibitor or HT/MTOR inhibitor for treatment of metastatic breast cancer. If the tumor has known PIK3CA mutation, HT/Alpelisib combination should be considered unless not a candidate for this therapy.
  • Experimental: AG-01 1B NSCLC
    Subjects with metastatic/recurrent NSCLCA failed 2 or more SOC therapies, including platinum-based chemotherapy and an anti-PD (L) -1 agent (sequentially or consecutively), Subjects with sensitizing mutations/alterations/rearrangements are eligible if received 1 or more SOC agent/s targeting these mutations unless not a candidate for these therapies.
  • Experimental: AG-01-1B mesothelioma
    Subjects with mesothelioma who received at least 1 SOC therapy for metastatic/recurrent mesothelioma per NCCN guidelines or not a candidate for SOC therapy.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD) [ Time Frame: 28 days during 1st cycle ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Katherine Tkaczuk, MD
[email protected]
410-328-7394
Amelia Barkman, MHA/CCRP
[email protected]
443-825-2456
Katherine Tkaczuk, MD (PRINCIPAL_INVESTIGATOR)
Renee Mehra, MD (SUB_INVESTIGATOR)
Paula Rosenblatt, MD (SUB_INVESTIGATOR)

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By research site
University of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MD

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