Phase 1 Colorectal Cancer Trial, Recruiting NCT05464030 Sponsor: EMD Serono Research & Development Institute, Inc. Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT05464030
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 who have been diagnosed with locally advanced or metastatic colorectal cancer (cancer that has spread beyond the colon or rectum), confirmed by a tissue sample, and whose cancer has stopped responding to or who could not tolerate standard treatments — and, where applicable, people with a specific tumor type called MSI-H who have already received a type of treatment called an immune checkpoint inhibitor, unless it was not suitable for them.
  • People whose general health and ability to carry out daily activities meets a specific level set by doctors (known as ECOG performance status of 0 or 1, meaning fully active or able to carry out light activity).
  • People whose blood counts, liver function, and kidney function are within the ranges required by the trial.
  • Other criteria defined in the trial protocol may also apply (confirm with trial site).

Who may not be able to join:

  • People who have had another type of cancer within the past 3 years, with some exceptions such as certain skin cancers, early-stage cervical changes, benign prostate conditions, or cancers considered fully cured with very low chance of returning (confirm with trial site).
  • People with cancer that has spread to the brain, unless those brain metastases have already been treated, have been stable for at least 4 weeks, and are not currently causing neurological symptoms related to the cancer itself.
  • People experiencing diarrhea (loose or liquid stools) or bowel blockage rated as moderate or severe.
  • People with active ongoing inflammatory bowel conditions such as ulcerative colitis, Crohn's disease, intestinal perforation, or a bowel obstruction.
  • People with certain serious heart conditions — including unstable chest pain, a recent heart attack, moderate-to-severe heart failure, or a heart procedure in the past 180 days — or people with a specific abnormality on a heart tracing (ECG) measurement above a set threshold.
  • People who have had a stroke within the past 6 months.
  • Other criteria defined in the trial protocol may also apply (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 14 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: Medical Responsible, EMD Serono Research & Development Institute, Inc.

Phone: 888-275-7376

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
Sponsor
EMD Serono Research & Development Institute, Inc.
Registry
ClinicalTrials.gov
Start date
4 August 2022
Est. completion
23 October 2026

Where this trial is recruiting

🇨🇦 Canada 🇯🇵 Japan 🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs); Part 1: Recommended Dose Expansion (RDE) of M9140; Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs); Part 2A: Number of Participants with Adverse Events (AEs); Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators; Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investi...

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: 14 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