Phase 1 Kidney Cancer Trial, Recruiting NCT04715191 Sponsor: Baylor College of Medicine Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT04715191
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 aged 1 to 21 years old
  • People who have a solid tumour that tests positive for a protein called GPC3, confirmed by a laboratory test showing a strong enough level of that protein in the tumour cells
  • People whose general health and ability to carry out daily activities meets a minimum score on a standard medical scale (called the Lansky or Karnofsky scale), indicating they are reasonably functional
  • People with a life expectancy of at least 16 weeks
  • People whose disease has come back or has not responded to standard treatments, and where a cure is no longer considered achievable with current therapies
  • People who have recovered from the side effects of any previous cancer treatments before entering the trial
  • People with liver cancer (hepatocellular carcinoma specifically) whose disease falls within a certain stage range (Barcelona Clinic Liver Cancer Stage A, B, or C) and whose liver function meets a specific scoring threshold (confirm with trial site)
  • People whose kidneys, liver, blood counts, and oxygen levels meet minimum required levels as measured by blood and other tests
  • People who are sexually active and are willing to use effective contraception for 6 months after receiving the treatment
  • People (or their parent or guardian) who have been given a full explanation of the trial, understand it, and have signed a consent form

Who may not be able to join:

  • People who have previously had an allergic reaction to products containing mouse proteins, or who have developed antibodies against mouse proteins (relevant only if prior mouse-based antibody treatments were received)
  • People who have had an organ transplant
  • People who are known to be HIV positive
  • People who have an active bacterial, fungal, or viral infection (certain Hepatitis B and Hepatitis C cases may still be considered if specific treatment conditions are met — confirm with trial site)
  • People who are pregnant or breastfeeding
  • People with an uncontrolled infection at the time of treatment
  • People who are currently taking systemic steroid medications at or above a certain dose, unless those medications are reduced or stopped at least 24 hours before the treatment infusion
  • People with certain serious heart conditions, including severe heart failure, unstable chest pain, serious irregular heartbeat, a heart attack within the past 6 months, or a history of heart muscle inflammation
  • People with an active autoimmune or inflammatory condition
  • People who have received a live vaccine within 30 days before joining the trial

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 22 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: David Steffin, MD, Baylor College of Medicine

Phone: (832) 824-4233

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
Registry
ClinicalTrials.gov
Start date
24 May 2024
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Patients with Dose Limiting Toxicity

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: 22 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