Phase 2 Melanoma Trial, Recruiting NCT04386967 Sponsor: Binhui Biopharmaceutical Co., Ltd. Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT04386967
Recruiting Phase 2

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 have been diagnosed with an advanced (stage III or IV) cancer that cannot be treated with surgery, confirmed by lab tests — including breast cancer, stomach/intestinal cancer, liver cancer, cervical cancer, melanoma, head and neck cancers, or soft tissue sarcomas (melanoma patients are especially prioritised in one phase of the trial).
  • Standard treatments have not worked for you, are no longer available to you, or your cancer has come back after treatment.
  • You are between 18 and 75 years old, are in reasonably good general health (able to carry out daily activities with little or no limitation), and doctors expect you to live for more than 3 months.
  • Any previous cancer treatments (such as chemotherapy, radiotherapy, hormone therapy, or targeted therapy) ended at least 4 weeks ago (or 6 weeks ago for certain specific chemotherapy drugs), and any side effects from those treatments have mostly cleared up.
  • If you have had major surgery, it was at least 4 weeks ago.
  • You have at least one tumour that can be injected directly and is large enough to be measured on a scan (longest measurement at least 10 mm, or at least 15 mm for lymph node tumours).
  • Your main organs (heart, kidneys, liver, etc.) are working well enough, with blood test results within acceptable ranges for blood cell counts, kidney function, liver function, and blood clotting (confirm specific values with the trial site).
  • If you are a woman of childbearing age, or a man whose partner could become pregnant, you agree to use effective contraception during the trial and for at least 3 months afterwards.
  • If you have ever had genital herpes, at least 3 months have passed since the last outbreak.
  • You are willing to give your informed consent to take part and are expected to be able to follow the trial requirements.

Who may not be able to join:

  • You have serious other health conditions such as severe heart disease, stroke-related disease, poorly controlled diabetes, poorly controlled high blood pressure, serious ongoing infection, active stomach or bowel ulcers, or certain immune system disorders (such as rheumatoid arthritis, lupus, or Sjögren's syndrome).
  • You had a different type of cancer (other than the one being treated) in the past 3 years — this applies if you would be receiving the combination drug treatment.
  • You have a current or past condition that weakens the immune system — this applies if you would be receiving the combination drug treatment.
  • You have previously been treated with certain immune checkpoint drugs (PD-1, PD-L1, or PD-L2 inhibitors) — this applies if you would be receiving the combination drug treatment.
  • You have an autoimmune disease (such as autoimmune lung disease or kidney inflammation) that required treatment with steroids or immune-suppressing drugs within the past 2 years — mild conditions like hay fever or childhood asthma may be exceptions; this applies if you would be receiving the combination drug treatment.
  • Your cancer has spread to the brain in a way that is not under control, or you have an uncontrolled brain tumour.
  • You have a mental health condition or an infectious disease that is not under control.
  • Your tumour cannot be injected directly (e.g. it is too small or not accessible).
  • You are pregnant or currently breastfeeding.
  • You have received another experimental treatment or antiviral medication within the past 4 weeks.
  • You have taken part in another clinical trial within the past 4 weeks.
  • You have a known allergy to herpes virus-based treatments or any ingredients in the study drug.
  • The trial doctors have any other concern that makes participation unsuitable for you (confirm with trial site).

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 2 July 2026
Phase 2: approximately ~30% 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Binhui Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
22 November 2018
Est. completion
13 March 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors; The dose-limiting toxicity (DLT) of OH2 injection and Keytruda in patients with solid tumors; The maximum-tolerated dose (MTD) of OH2 injection in combination with Keytruda in patients with solid tumors

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: 2 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