Phase 2 Colorectal Cancer Trial, Recruiting NCT07589517 Sponsor: Beijing Biotech Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT07589517
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 colorectal cancer (a specific type called adenocarcinoma) that has spread or cannot be removed by surgery, and standard treatments have stopped working, caused intolerable side effects, or are not an option for you.
  • Your cancer can be measured on scans according to standard medical guidelines (confirm with trial site if you have had recent surgery to remove tumors).
  • Your tumor tests positive for a specific combination of proteins — either CEA and GUCY2C, CEA and HER2, or GUCY2C and HER2 — as confirmed by a central laboratory.
  • You are generally well enough to carry out light daily activities, with only minor limitations (this is measured on a standard 0–1 scale that the trial team will assess).
  • Your blood, kidneys, liver, and heart are functioning well enough to meet the trial's requirements (the trial team will check this with tests).
  • Any side effects from previous cancer treatments have mostly cleared up, with only mild issues remaining (some exceptions, like mild nerve tingling or hair loss, may be acceptable).
  • You are expected to live for at least 12 weeks or more.
  • You are willing to use effective birth control during the trial and for a set period after treatment (confirm exact timeframe with trial site).

Who may not be able to join:

  • You have an active infection that is not under control, including uncontrolled hepatitis B, hepatitis C, or HIV.
  • You have cancer that has spread to the brain or spinal cord and is currently causing symptoms or requires increasing doses of steroids (previously treated and stable brain metastases may be considered — confirm with trial site).
  • You have received a certain type of gene-modified cell therapy (such as CAR-T cell therapy) within the past 6 months, or any prior treatment that the doctor believes could increase your risk of serious side effects.
  • You have a significant autoimmune disease (where the immune system attacks your own body) that has required medication to suppress your immune system within the last 6 months.
  • You are currently receiving other cancer treatments at the same time as this trial (with some limited exceptions the trial team may permit).
  • You are currently pregnant or breastfeeding.
  • You have serious heart problems (such as a recent heart attack or an uncontrolled irregular heartbeat), uncontrolled lung disease, or another severe health condition that could increase the risks of participating.
  • You have a known allergy or sensitivity to certain chemotherapy drugs used in this trial (fludarabine or cyclophosphamide) or to other required medications.
  • You have any other condition that, in your doctor's opinion, could make it unsafe for you to participate or make it difficult to monitor your health during 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 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
Beijing Biotech
Registry
ClinicalTrials.gov
Start date
2 February 2026
Est. completion
14 March 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of dose-limiting toxicities (DLTs) graded by CTCAE v5.0.; Maximum tolerated dose (MTD); Objective response rate (ORR) by RECIST v1.1 in the expansion cohort.

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