Phase 1 Mesothelioma Trial, Recruiting NCT05627960 Sponsor: A&G Pharmaceutical Inc. Condition: Mesothelioma
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Phase 1 Mesothelioma Trial, Recruiting

NCT05627960
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years of age or older.
  • You must have been diagnosed with advanced cancer, confirmed by a tissue or cell sample test.
  • Your cancer must show at least one measurable tumor that can be seen on a scan.
  • You must have tried one or more standard cancer treatments that did not work, and no standard treatment options remain (for the early phase of the trial).
  • For a later phase of the trial, your tumor tissue must show a certain protein called GP88 when tested; a stored tissue sample can usually be used for this.
  • At least 4 weeks must have passed since your last chemotherapy or radiation treatment (6 weeks for certain specific drugs — confirm with trial site).
  • You must be well enough to carry out some daily activities (your doctor can assess this using a standard scale).
  • Your liver, kidneys, and bone marrow must be working well enough, based on blood tests.
  • You must be willing to use highly effective birth control during the trial and for 90 days after it ends (if you or your partner could become pregnant).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining.
  • Your life expectancy must be greater than 12 weeks.
  • If you have triple negative breast cancer, you must have already tried one or more standard treatments for advanced disease (specific requirements apply depending on your tumor type — confirm with trial site).
  • If you have hormone-sensitive breast cancer that is no longer responding to hormonal treatment, you must have tried one or more hormonal therapies for advanced disease (confirm with trial site).
  • If you have a certain type of lung cancer (non-small cell), you must have tried at least 2 standard treatments, including a platinum-based chemotherapy and an immunotherapy drug (confirm with trial site).
  • If you have mesothelioma, you must have received at least one standard treatment, or not be a suitable candidate for standard treatment.
  • People of all ethnic backgrounds are welcome to apply.

Who may not be able to join:

  • You may not be eligible if you have serious uncontrolled health conditions, such as severe heart problems, a heart attack within the last 6 months, or mental health or personal circumstances that would make it hard to follow the study rules.
  • You may not be eligible if your cancer has spread to the brain and is not being controlled or treated (treated and stable brain metastases may be allowed — confirm with trial site).
  • You may not be eligible if cancer has spread to the membranes surrounding your brain or spinal cord.
  • You may not be eligible if you are currently taking part in another clinical trial or have done so within the last 28 days.
  • You may not be eligible if you are pregnant or currently breastfeeding.
  • You may not be eligible if you are unable or unwilling to use effective birth control as required by the study.
  • You may not be eligible if you have had another type of cancer in the last 2 years (some exceptions may apply for certain minor skin cancers — confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Katherine Tkaczuk, MD, University of Maryland, Baltimore

Phone: (410)884-4100

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
A&G Pharmaceutical Inc.
Registry
ClinicalTrials.gov
Start date
14 February 2022
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD) and/or Maximum Administered Dose (MAD); Antitumor Activity of AG-01 by Overall Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov