Phase 2 Colorectal Cancer Trial, Recruiting NCT06434597 Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT06434597
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 diagnosed with advanced colorectal cancer (that has spread or cannot be removed by surgery), or advanced bile duct cancer (that is locally advanced, has come back, spread, or cannot be removed by surgery)
  • People whose cancer tests positive for a protein called HER2, or who have a mutation (change) in the HER2 gene
  • People who meet the trial's requirements regarding previous cancer treatments received (confirm with trial site)
  • People whose general health and ability to carry out daily activities is rated at a 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations
  • People whose life expectancy is at least 3 months
  • People with no serious problems with blood cell production, liver function, or kidney function
  • People who are not pregnant and not breastfeeding, and who are willing to follow the contraception requirements set out in the trial protocol
  • People who have been fully informed about the trial and have voluntarily signed a consent form

Who may not be able to join:

  • People who have previously received any targeted therapy directed at HER2
  • People who have taken part in another clinical trial and received a study drug within the 4 weeks before the first dose of this trial
  • People with uncontrolled or serious heart, blood vessel, or brain blood vessel disease, or serious lung disease
  • People who have a condition that the trial doctor believes may affect how the study drug is absorbed, broken down, or removed by the body
  • People who are currently taking strong medications that interact with certain liver enzymes called CYP3A4 or CYP2C8 (confirm with trial site)
  • People who have had a different type of cancer in the past 5 years
  • People who have cancer that has spread to the brain or central nervous system and is causing symptoms
  • People who do not meet the trial's requirements regarding hepatitis B or C infection status, who have a history of immune system deficiency (including inherited or acquired conditions), or who have had an organ transplant
  • People who do not meet other requirements set out in the trial protocol (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 15 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: 0086-010-66937166

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
Shanghai Pharmaceuticals Holding Co., Ltd
Registry
ClinicalTrials.gov
Start date
17 July 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate (ORR)

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: 15 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