Phase 1 Melanoma Trial, Recruiting NCT06636435 Sponsor: Chiome Bioscience Inc. Condition: Melanoma
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Phase 1 Melanoma Trial, Recruiting

NCT06636435
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:

Parts 1–4 (Adults):

  • People who give their own written agreement to take part in the study voluntarily
  • People who are generally well enough to carry out light activity or desk work (a standard health scoring system rates them at 0 or 1 out of 5)
  • People whose kidneys are working well enough, based on a blood test taken within 7 days before joining
  • People whose blood counts are within acceptable ranges (white blood cells, platelets, and red blood cells), based on a blood test taken within 7 days before joining
  • People with a solid tumour (a type of cancer that forms a mass) for which no standard treatment is available, or whose cancer has stopped responding to standard treatment, or who could not tolerate standard treatment (Parts 2 and 3)
  • People with a certain level of liver function, classified as Child-Pugh A or B (a liver health score used by doctors) — (confirm with trial site) (Parts 2 and 3)
  • People with malignant melanoma (a type of skin cancer) whose cancer has stopped responding to standard treatment or who could not tolerate it (Part 4)

Part 5 (Children and Young People):

  • People who give written agreement to take part, with consent provided by both the young person (if aged 16 or older) and their legal guardian
  • Japanese patients aged 2 years or older and under 20 years old at the time of consent
  • Young people whose general health and ability to function meets a minimum score on age-appropriate scales used by doctors (70 or above out of 100)
  • People whose kidneys are working well enough, based on a specific blood test taken within 7 days before joining
  • Children and young people with cancer for which no standard treatment is available, or whose cancer has stopped responding to standard treatment, or who could not tolerate it

Who may not be able to join:

  • People who had major surgery within the 28 days before joining
  • People who received any cancer treatment — including surgery, radiation, or drug therapy — within the 14 days before joining
  • People who received an immune checkpoint inhibitor (a type of cancer drug that works with the immune system) or similar treatment within the 28 days before joining
  • People who have ongoing side effects from a previous illness or treatment that are rated moderate or severe (Grade 2 or higher)
  • People who took part in another clinical trial involving an experimental treatment within the 28 days before joining
  • People with heart disease or heart problems that are currently not well controlled or are considered medically significant
  • People whom the doctor running the trial considers unsuitable 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 14 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: +81-3-6383-3561

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
Chiome Bioscience Inc.
Registry
ClinicalTrials.gov
Start date
1 June 2020
Est. completion
30 June 2027

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Dose limiting toxicity; Adverse Event

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: 14 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