Phase 1 Leukaemia Trial, Recruiting NCT05190471 Sponsor: Bio-Path Holdings, Inc. Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05190471
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 are 18 years of age or older and have been diagnosed with acute myeloid leukemia (AML) that has come back or stopped responding to available treatments
  • You are able to carry out basic daily activities, with your overall health and activity level falling within an acceptable range as rated by your doctor (a score of 0, 1, or 2 on a standard scale)
  • In the later part of the trial, you may be eligible if you have AML and your doctor considers you suitable for a specific chemotherapy medicine called decitabine
  • Your liver is working well enough, shown by specific blood test results being within acceptable ranges (confirm with trial site)
  • Your kidneys are working well enough, shown by your kidney filtering rate being at least 60 mL/min as calculated by your doctor (confirm with trial site)
  • If you are a woman who could become pregnant, you must agree to use an accepted form of birth control throughout the study and for at least 6 months after your last dose
  • If you are a man, you must agree to use an accepted form of contraception for the duration of the study
  • You have fully recovered from any past surgery, radiation, or cancer treatment side effects (hair loss is an exception)
  • You are willing and able to sign a written consent form agreeing to take part in the trial

Who may not be able to join:

  • You have another active cancer (not a blood or lymph node cancer) that has been treated with cancer-fighting medicines or therapies in the past 12 months
  • You have leukemia that has spread to the fluid around your brain or spinal cord and is currently being actively treated (confirm with trial site)
  • Your leukemia is only found outside the bone marrow and does not also meet the bone marrow requirements for AML (confirm with trial site)
  • You have a specific type of leukemia called acute promyelocytic leukemia (APL) with a particular genetic change
  • You have chronic myeloid leukemia (CML) at any stage
  • You have received any cancer treatment within 14 days before starting the trial, with limited exceptions such as a medicine called hydroxyurea or a blood-filtering procedure
  • You are currently taking part in another clinical trial involving an experimental treatment
  • You are pregnant or breastfeeding
  • You have substance use, medical, mental health, or social issues that could affect your ability to take part in or complete the study
  • You have HIV with a low immune cell count, or you have an active hepatitis B or C infection
  • You have had a previous allergic reaction to a type of cancer medicine called a hypomethylating agent (confirm with trial site)
  • You still have unresolved side effects from a previous treatment that are above a mild level (hair loss is an exception)
  • You have serious heart conditions, such as severe heart failure, uncontrolled high blood pressure, a significant irregular heartbeat, or an abnormal heart reading on an ECG
  • In the past 6 months, you have had a heart attack, unstable chest pain, heart or artery bypass surgery, a stroke, or a mini-stroke
  • You have had seizures within the past 2 months that are not controlled
  • You are unwilling or unable to communicate with the study team or follow the study rules for any reason

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 7 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: Gail J Roboz, MD, Weill Cornell Medical College - New York-Presbyterian Hospital

Phone: 832-742-1361

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
Bio-Path Holdings, Inc.
Registry
ClinicalTrials.gov
Start date
16 August 2022
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Identify Dose Limiting Toxicity (DLT) of BP1002; Identify and grade treatment-emergent adverse events (TEAE) of escalating doses of BP1002; Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002; Recommended Phase 2 (RP2D) of BP1002; Determine plasma pharmacokinetics (PK) of BP1002 using maximum plasma drug concentration; Determine plasma pharmacokinetics (PK) of BP1002 using volume of distribution; Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant; Determine half-life plasma pharmacokinetics (PK) of BP1002; Identify conducti...

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: 7 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