Phase 1 Breast Cancer Trial, Recruiting NCT07101601 Sponsor: DIGMBIO Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT07101601
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:

  • Adults aged 19 years or older at the time of signing the consent form
  • People who have at least one tumour that can be measured using standard imaging guidelines (called RECIST v1.1)
  • People whose general physical functioning meets a specific standard (ECOG score of 0 or 1, meaning fully active or able to carry out light activities — confirm with trial site)
  • People with a life expectancy of at least 12 weeks
  • People whose blood test results show that their liver, kidneys, and blood cell counts are within acceptable ranges
  • People who voluntarily sign a written consent form agreeing to take part in the study
  • People whose cancer has been confirmed by laboratory testing of tissue or cell samples, and whose tumour cannot be removed by surgery and has reached an advanced stage
  • People whose cancer carries a mutation in the BRCA1 or BRCA2 gene

Who may not be able to join:

  • People with a history of a significant medical illness (confirm with trial site for specifics)
  • People whose heart's electrical activity shows a prolonged QT interval — greater than 450 ms for men or greater than 460 ms for women — on a heart tracing test
  • People who are still experiencing side effects from a previous cancer treatment that have not yet resolved
  • People considered likely to have a serious allergic reaction to any ingredient in the study drug
  • People who have previously taken part in another clinical trial and received an investigational drug or medical device as part of that trial
  • People the trial investigator considers unsuitable for participation for any other 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 8 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: +82 31 757 220

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
DIGMBIO
Registry
ClinicalTrials.gov
Start date
24 October 2024
Est. completion
30 October 2026

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

Part 1: Incidence of dose limiting toxicities (DLT) of DM5167; Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs)

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: 8 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