Phase 1 Leukaemia Trial, Recruiting NCT05304377 Sponsor: Enliven Therapeutics Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05304377
Recruiting Phase 1 🇦🇺 Australian site

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:

  • People who have been diagnosed with chronic phase CML (a type of blood cancer) that tests positive for a gene change called BCR-ABL1, with or without a specific mutation called T315I.
  • In the US: People whose CML has stopped responding to, or who could not tolerate, at least one prior second-generation targeted cancer medicine (called a tyrosine kinase inhibitor) or a drug called asciminib.
  • Outside the US: People whose CML has stopped responding to, who could not tolerate, or who are not suitable candidates for, available CML treatments (specific requirements may vary by country — confirm with trial site).
  • People who are reasonably active and able to care for themselves, based on a standard medical scoring system (rated 0 to 2 on the ECOG scale — confirm with trial site).
  • People whose blood counts, liver, and kidneys are functioning at an adequate level.
  • People who have previously had a bone marrow transplant, provided it was at least 6 months before starting the trial drug ELVN-001.

Who may not be able to join:

  • People who have received any cancer treatment or CML treatment within the past 7 days, or within 5 half-lives of that treatment (whichever period is longer).
  • People who have had a severe episode of pancreas inflammation (pancreatitis) related to a targeted cancer medicine within the past 6 months, or who currently have ongoing pancreatitis or any other pancreatic condition.
  • People whose heart electrical reading (ECG) shows a specific measurement called QTc that is greater than 470 milliseconds, indicating a heart rhythm concern.

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 23 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

Phone: 707-799-3272

Australian sites

Royal Adelaide Hospital, Adelaide,
+61 8 7074 0000

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
Enliven Therapeutics
Registry
ClinicalTrials.gov
Start date
22 May 2022
Est. completion
1 December 2027

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase 1a: Incidence of dose limiting toxicities; Phase 1a: Incidence of adverse events (AEs); Phase 1a: Incidence of clinically significant laboratory abnormalities; Phase 1a: Incidence of clinically significant ECG abnormalities; Phase 1b: Incidence of adverse events; Phase 1b: Incidence of clinically significant laboratory abnormalities; Phase 1b: Incidence of clinically significant ECG abnormalities

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: 23 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