Phase 1 Stomach Cancer Trial, Recruiting NCT04282044 Sponsor: BioEclipse Therapeutics Condition: Stomach Cancer
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Phase 1 Stomach Cancer Trial, Recruiting

NCT04282044
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:

  • You are 18 years old or older
  • You have been diagnosed (confirmed by a tissue sample/biopsy) with one of these specific cancers: triple-negative breast cancer, colon or rectal cancer, liver cancer (hepatocellular carcinoma), bone cancer (osteosarcoma), ovarian cancer, melanoma (skin cancer), non-small cell lung cancer, or stomach cancer
  • Your cancer has come back, stopped responding to treatment, or you have already tried the standard available treatments (or are not expected to benefit from them)
  • If you have ovarian cancer, you must have received at least one prior standard treatment that included a platinum-based chemotherapy drug
  • You are willing to provide a fresh tumor tissue sample (biopsy), or if a biopsy is not safely possible, older stored tissue samples can be used instead
  • Your cancer can be measured on a CT or MRI scan with contrast dye
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site for exact fitness level required)
  • You are expected to live for at least 12 weeks from when you join the trial
  • Your blood counts (white blood cells, red blood cells, and platelets) meet minimum levels set by the trial, without needing recent blood transfusions or growth factor injections to reach those levels
  • Your kidneys and liver are working well enough to meet the trial's specific requirements (confirm exact values with trial site)
  • If you could become pregnant, you must have a negative pregnancy test before joining
  • If you could become pregnant, you must agree to use highly effective contraception during the study and for six months after your last dose of the study treatment
  • If you are male and your partner could become pregnant, you must agree to use effective barrier contraception during the study and for six months after your last dose of the study treatment
  • You are willing and able to follow all study procedures and attend all follow-up appointments

Who may not be able to join:

  • You have new or worsening cancer spread to the brain (however, if brain metastases were previously treated and have been stable for at least four weeks, you may still be eligible — confirm with trial site)
  • You have received chemotherapy, immunotherapy, radiation therapy, or other experimental treatments within the last three weeks before joining
  • You are still experiencing significant side effects (grade 2 or higher) from previous cancer treatments such as surgery, radiation, or systemic therapies
  • You have received any cell-based therapy (such as CAR-T or similar treatments) within the last 12 weeks
  • You currently have an active infection (bacterial, viral, or fungal) that requires antibiotic, antiviral, or antifungal medication, or you need to take certain antiviral medications that could interfere with the study treatment
  • You have a history of active autoimmune disease (where your immune system attacks your own body) that required ongoing treatment in the past two years — some exceptions apply (confirm with trial site)
  • You are currently taking high-dose steroid medications or other immune-suppressing drugs (some exceptions apply, such as low-dose steroids, skin creams, or inhalers — confirm with trial site)
  • You have HIV, active hepatitis B or C, a life-threatening illness unrelated to your cancer, or a serious mental health condition that could interfere with taking part in the trial
  • You are pregnant or currently breastfeeding, or someone in your home is pregnant or breastfeeding
  • You or someone in your household has a significant problem with your immune system
  • You have serious heart problems, an unstable heart condition, or another significant medical or psychiatric condition that the trial doctor believes could affect your safe participation
  • You have a history of another cancer, unless you have been cancer-free and off treatment for at least two years, are considered low risk for that cancer returning, or had certain early-stage cancers (such as skin cancer, early prostate cancer, or pre-invasive cancers of the breast, mouth, or cervix) — confirm eligibility 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 27 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: Oliver Dorigo, MD, Stanford University

Phone: 206-229-5827

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
BioEclipse Therapeutics
Registry
ClinicalTrials.gov
Start date
8 January 2021
Est. completion
1 August 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities; Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level.

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: 27 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