Phase 2 Colorectal Cancer Trial, Recruiting NCT06589830 Sponsor: Suzhou Teligene Ltd. Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06589830
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:

  • People aged 18 or older, of any gender
  • People diagnosed with HER2-positive, RAS wild-type colorectal cancer that has spread or cannot be removed by surgery, and who have already received specific prior treatments including fluoropyrimidine, oxaliplatin, irinotecan, and a type of anti-VEGF antibody therapy; people whose tumours have certain genetic features (dMMR or MSI-H) must also have received a specific type of immunotherapy beforehand
  • People who have at least one tumour that can be measured on a scan
  • People with a general health performance score of 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to moderately limited in daily activity (confirm with trial site)
  • People with a life expectancy of more than 3 months
  • People with adequately functioning bone marrow, liver, kidneys, and blood clotting (confirm with trial site)
  • Additional inclusion criteria may apply — the trial site can provide full details

Who may not be able to join:

  • People who have previously received any anti-HER2 targeted therapy
  • People who have received chemotherapy or radiation therapy within 3 weeks before joining, immunotherapy within 4 weeks, or palliative (symptom-relieving) radiotherapy to non-target areas within 2 weeks before joining
  • People who have taken part in another interventional clinical trial within 2 weeks before joining, or within a period based on the last dose of the trial medicine (whichever is shorter)
  • People who have had major surgery (not including needle biopsies) or a significant injury within 4 weeks before joining
  • People who still have unresolved side effects from previous treatments rated above a mild level (Grade 1) at the time of screening
  • People with active, symptomatic cancer spread to the brain or central nervous system; people with brain metastases that cause no symptoms and have not required steroid treatment in the past 30 days may still be considered
  • People who have had another cancer within the past 3 years, with some exceptions such as treated skin basal cell carcinoma, cervical carcinoma in situ, low-grade prostate cancer, or ductal carcinoma in situ of the breast
  • People with an active infection that has not been brought under control at the time of screening
  • Additional exclusion criteria may apply — the trial site can provide full details

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 20 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.

Contact this trial

Phone: 8053009373

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 2
Sponsor
Suzhou Teligene Ltd.
Registry
ClinicalTrials.gov
Start date
13 May 2025
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose limiting toxicity, maximum tolerated dose, and recommended phase 2 dose; Objective Response Rate (ORR) by IRC

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: 20 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