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Monoclonal Antibodies

AG-01 Antibody Therapy for Advanced Cancers

Q: Has the AG-01 treatment group achieved approval by the FDA in phase 1A?

Taking into account the limited safety and efficacy data available, our team at Power determined AG-01's treated group Phase 1A to have a score of 1.

Q: What is the primary aim of this investigation?

A&#x26;G Pharmaceutical Inc., the clinical trial sponsor, has identified Antitumor Activity of AG-01 by Overall Response Rate (ORR) as the primary outcome that will be measured over a 28 day period during cycle 1. This study also seeks to evaluate secondary objectives such as determining preliminary anti-tumour activity with response assessed through RECIST 1.1 imaging every 56 days and collecting blood samples in cycles one, two, end of treatment and 30 days post-treatment for pharmacokinetic analysis. In order to estimate maximum tolerated dose and/or maximum administered dose (MAD), an accelerated titration design is applied which

Q: What is the number of eligible individuals for this clinical experiment?

Correct. According to the clinicaltrials.gov database, this trial began on February 14th 2022 and is still recruiting as of November 16th 2022. The study requires 77 participants from a single location.

Q: Can new participants still join this clinical experiment?

Affirmative. Clinicaltrials.gov hosts data which highlights that, since its inception on February 14th 2022, this trial is searching for 77 participants at 1 site.

Phase 1

Recruiting

Led By Katherine Tkaczuk, MD

Research Sponsored by A&G Pharmaceutical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males with partners at reproductive age must use highly effective birth control methods to prevent partners' pregnancy while on study and for 90 days after completion of study treatments

ECOG performance status must be ≤2 (Appendix A)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (cycle1 first dose), day 4, day 8, day 15 (cycle 1 second dose), day 29 (cycle 2 first dose), day 43 (cycle 2 second dose), day 46, day 50, day 57 (end of treatment) and day 87 (30 days post end of treatment).

Awards & highlights

Study Summary

This trial is testing a new antibody therapy to treat advanced solid cancers. It will assess its safety and effectiveness, and determine the best dose to use.

Who is the study for?

This trial is for adults with advanced solid tumors who have failed standard treatments. It includes those with specific types of lung, breast, and mesothelioma cancers. Participants must have measurable metastatic lesions, be in a stable condition, and use effective contraception. Those with certain recent malignancies or uncontrolled illnesses are excluded.Check my eligibility

What is being tested?

AG01, an anti-Progranulin/Glycoprotein88 antibody designed to target cancer cells, is being tested for safety and the maximum tolerated dose in phase 1A. Phase 1B will expand on this to find the optimal dose for future studies based on participants' responses.See study design

What are the potential side effects?

As AG01 is a new drug being tested for the first time in humans, potential side effects are not yet fully known but may include typical reactions related to monoclonal antibodies such as infusion reactions, immune-related issues, and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control to prevent pregnancy during and 90 days after the study.

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I am able to care for myself and perform daily activities.

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I have mesothelioma and have tried at least one standard treatment or cannot undergo standard treatments.

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My liver, kidney, and bone marrow are functioning well according to specific blood test results.

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I am of childbearing age and have a negative pregnancy test.

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My cancer is confirmed to be advanced through testing.

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My cancer has not responded to standard treatments.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (cycle1 first dose), day 4, day 8, day 15 (cycle 1 second dose), day 29 (cycle 2 first dose), day 43 (cycle 2 second dose), day 46, day 50, day 57 (end of treatment) and day 87 (30 days post end of treatment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (cycle1 first dose), day 4, day 8, day 15 (cycle 1 second dose), day 29 (cycle 2 first dose), day 43 (cycle 2 second dose), day 46, day 50, day 57 (end of treatment) and day 87 (30 days post end of treatment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (cycle1 first dose), day 4, day 8, day 15 (cycle 1 second dose), day 29 (cycle 2 first dose), day 43 (cycle 2 second dose), day 46, day 50, day 57 (end of treatment) and day 87 (30 days post end of treatment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antitumor Activity of AG-01 by Overall Response Rate (ORR)

Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD)

Secondary outcome measures

Anti-drug antibodies (ADA) to AG-01

Pharmacokinetic (PK) profile of AG-01-1A

Preliminary anti-tumor activity of the AG-01 in subjects with refractory/advanced solid tumor malignancies (1A and 1B).

+2 more

Other outcome measures

Serial Glycoprotein88 (GP-88) blood levels

Trial Design

5Treatment groups

Experimental Treatment

Group I: AG-01-1B mesotheliomaExperimental Treatment1 Intervention

Subjects with mesothelioma who received at least 1 SOC therapy for metastatic/recurrent mesothelioma per NCCN guidelines or not a candidate for SOC therapy.

Group II: AG-01 treated group phase 1AExperimental Treatment1 Intervention

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.

Group III: AG-01 1B triple negative breast cancer treated groupExperimental Treatment1 Intervention

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.

Group IV: AG-01 1B NSCLCExperimental Treatment1 Intervention

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.

Group V: AG-01 1B Hormone-resistant breast cancerExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

A&G Pharmaceutical Inc.Lead Sponsor

University of Maryland Greenebaum Cancer CenterOTHER

14 Previous Clinical Trials

349 Total Patients Enrolled

Katherine Tkaczuk, MDPrincipal InvestigatorUniversity of Maryland, Baltimore

3 Previous Clinical Trials

426 Total Patients Enrolled

Media Library

AG01 Compound (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05627960 — Phase 1

Non-Small Cell Lung Cancer Research Study Groups: AG-01 1B NSCLC, AG-01 1B Hormone-resistant breast cancer, AG-01-1B mesothelioma, AG-01 treated group phase 1A, AG-01 1B triple negative breast cancer treated group

Non-Small Cell Lung Cancer Clinical Trial 2023: AG01 Compound Highlights & Side Effects. Trial Name: NCT05627960 — Phase 1

AG01 Compound (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627960 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the AG-01 treatment group achieved approval by the FDA in phase 1A?

"Taking into account the limited safety and efficacy data available, our team at Power determined AG-01's treated group Phase 1A to have a score of 1."

Answered by AI

What is the primary aim of this investigation?

"A&G Pharmaceutical Inc., the clinical trial sponsor, has identified Antitumor Activity of AG-01 by Overall Response Rate (ORR) as the primary outcome that will be measured over a 28 day period during cycle 1. This study also seeks to evaluate secondary objectives such as determining preliminary anti-tumour activity with response assessed through RECIST 1.1 imaging every 56 days and collecting blood samples in cycles one, two, end of treatment and 30 days post-treatment for pharmacokinetic analysis. In order to estimate maximum tolerated dose and/or maximum administered dose (MAD), an accelerated titration design is applied which"

Answered by AI

What is the number of eligible individuals for this clinical experiment?

"Correct. According to the clinicaltrials.gov database, this trial began on February 14th 2022 and is still recruiting as of November 16th 2022. The study requires 77 participants from a single location."

Answered by AI

Can new participants still join this clinical experiment?

"Affirmative. Clinicaltrials.gov hosts data which highlights that, since its inception on February 14th 2022, this trial is searching for 77 participants at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05627960.

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