First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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).
Sponsor: A&G Pharmaceutical Inc.
You may qualify if…
- ✓ 1. Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
- ✓ 2. 18 years of age or older.
- ✓ 3. Histologic or cytologic diagnosis of advanced cancer.
- ✓ 4. Radiographic evidence of at least 1 measurable metastatic lesion per RECIST 1.1 criteria.
- ✓ 5. Patients with relapsed/refractory solid tumor malignancies who failed one or more standard chemotherapy or targeted therapy regimens per SOC guidelines such as NCCN guidelines and for whom no standard therapy exists (Phase 1A). No GP88 expression pre-required for phase 1A.
- ✓ 6. For phase 1B, patients must have GP88 tissue tumor tissue expression of 1+, 2+ or 3+ by IHC, archival tumor tissue will be used whenever possible. If no archival tissue is available, subject will be asked to consent to a study specific tumor biopsy for GP88 testing (phase1B). Patients who do not have archival tissue available for the dose expansion cohort (1B) will not be exposed to significant risk procedure to obtain tissue and may still be eligible for the study, after discussion with the Sponsor and Medical Monitor.
- ✓ 7. At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy.
- ✓ 8. ECOG performance status must be ≤2 (Appendix A).
You may not qualify if…
- ✕ 1. Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- ✕ 2. Uncontrolled or untreated CNS metastases and treated CNS metastases are allowed, as long as the patient is clinically stable.
- ✕ 3. Presence carcinomatous meningeal involvement.
- ✕ 4. Patients may not be receiving any other investigational agents, or have participated in any investigational drug study \< 28 days prior to starting on the current study.
- ✕ 5. Since the teratogenic potential of AG01 is currently unknown, females who are pregnant or lactating are excluded.
- ✕ 6. Males and females unable to adhere to abstinence or use highly effective methods of contraception (annual failure rate \< 1%) to prevent study subjects' pregnancy or study subjects' partner pregnancy.
- ✕ 7. History of any other malignancies in the last 2 years except for in-situ cancer, basal or squamous cell skin cancer treated with curative intent.
Where it's recruiting
Baltimore
Source: ClinicalTrials.gov · NCT05627960 · last updated 2022-11-28