Phase 1 Melanoma Trial, Recruiting NCT06805825 Sponsor: Novelty Nobility, Inc. Condition: Melanoma
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Phase 1 Melanoma Trial, Recruiting

NCT06805825
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:

  • People who have been diagnosed (confirmed by lab testing of tissue or cells) with one of these cancer types that is advanced, has spread, or cannot be removed by surgery: GIST (gastrointestinal stromal tumour), small cell lung cancer (SCLC), adenoid cystic carcinoma (ACC), uveal melanoma (a type of eye cancer), neuroendocrine tumour (NET), chromophobe renal cell carcinoma (ChRCC), or clear cell renal cell carcinoma (ccRCC)
  • People with GIST who have already received at least one course of a drug called imatinib, or people with the other listed cancer types whose cancer has stopped responding to standard treatments, who are not suitable for standard treatments, who cannot tolerate standard treatments, or who have chosen not to receive standard treatments
  • People whose general health and ability to carry out daily activities is rated at a good to moderate level (a score of 0 or 1 on a standard medical scale)
  • People whose doctor estimates they are expected to live for at least 3 months before starting treatment in this trial
  • People aged 18 years or older
  • People whose kidney, liver, and bone marrow are functioning at an adequate level, as shown by recent blood test results
  • People whose heart is functioning adequately, as confirmed by a heart imaging scan
  • People who have waited a sufficient amount of time since their last cancer treatment before joining the trial (the required waiting period varies depending on the type of treatment previously received, ranging from 14 days to 6 weeks)
  • People who test negative for pregnancy at the time of screening (where applicable)
  • People who are able to use contraception throughout the trial and for 120 days after the last dose, and who agree to refrain from donating sperm during that same period — or people who are confirmed to be post-menopausal or surgically sterile
  • People who are willing and able to give written consent and follow all parts of the trial plan

Who may not be able to join:

  • People with any cancer other than GIST who have previously received a c-Kit targeted treatment
  • People who have brain metastases (cancer that has spread to the brain) that are untreated, causing symptoms, or currently requiring treatment to manage symptoms
  • People who have been taking high-dose steroid tablets or other medicines that suppress the immune system within the 14 days before starting the trial (inhaled steroids are generally allowed)
  • People who still have significant side effects from previous cancer treatments that have not sufficiently resolved
  • People who have had major surgery within 30 days before starting the trial
  • People with significant heart problems
  • People with significant abnormalities on a heart rhythm (ECG) test
  • People with a known active and clinically significant bacterial, fungal, or viral infection
  • People with high blood pressure that has not been adequately controlled despite treatment
  • People who have had a blood clot in a vein or in the lungs within the 3 months before screening
  • People who have an ongoing infection that requires intravenous (drip) antibiotics or other systemic treatment, or who have an active COVID-19 infection
  • People with another serious illness that, in the trial doctor's judgement, would significantly increase the risks of taking part
  • People who are pregnant or breastfeeding

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

Principal Investigator: Sunil Sharma, MD, Novelty Nobility

Phone: 1 617.870.7173

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
Novelty Nobility, Inc.
Registry
ClinicalTrials.gov
Start date
3 February 2025
Est. completion
30 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of subjects with Dose-limiting Toxicities:; Incidence of Adverse Events:

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