Phase 2 Colorectal Cancer Trial, Recruiting NCT07259590 Sponsor: Genfleet Therapeutics (Shanghai) Inc. Condition: Colorectal Cancer
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Phase 2 Colorectal Cancer Trial, Recruiting

NCT07259590
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 who are willing to take part voluntarily and sign a consent form.
  • People aged 18 or older for Treatment Arm A, or between 18 and 75 years old for Treatment Arm B.
  • People who have been diagnosed (through tissue or cell testing) with a locally advanced, inoperable, or metastatic solid tumour that has a specific genetic change called a KRAS G12D mutation.
  • People whose cancer has not responded to standard treatments, who could not tolerate standard treatments, for whom standard treatments are not appropriate, or for whom no standard treatment exists.
  • People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1).
  • People with a certain level of general physical fitness, assessed using a standard scale called ECOG Performance Status — a score of 0–2 for Arm A, or 0–1 for Arm B (confirm with trial site).
  • People whose liver, kidneys, and other organs are functioning at a sufficient level.

Who may not be able to join:

  • People who have brain metastases causing symptoms, cancer spreading to the membranes around the brain or spinal cord, spinal cord compression, or a primary brain tumour.
  • People who have other known genetic changes that are driving their cancer, in addition to KRAS G12D.
  • People with a past or current history of significant heart or cardiovascular problems.
  • People who currently have an active infection.
  • People with a history of significant central nervous system (brain or spinal cord) conditions.
  • People with significant lung conditions such as interstitial lung disease, radiation-related lung inflammation, or immune-related lung inflammation that requires treatment.
  • People who have been diagnosed with a blood clot in a deep vein or in the lungs within the 3 months before starting the trial treatment.
  • People who have fluid build-up around the lungs, in the abdomen, or around the heart that is uncontrolled or causing symptoms.
  • People who have had major surgery within 28 days before the trial starts, a major physical injury within 14 days before the trial starts, or who are planning major surgery during the trial period.
  • People who have received radiotherapy within 4 weeks before the trial starts, or targeted bone radiotherapy within 2 weeks before the trial starts.

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 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

Principal Investigator: Lin Shen, MD, Peking University Cancer Hospital & Institute

Phone: +8618073129952

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
Genfleet Therapeutics (Shanghai) Inc.
Registry
ClinicalTrials.gov
Start date
21 October 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events; Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE); Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1

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