Phase 1 Pancreatic Cancer Trial, Recruiting NCT07166601 Sponsor: EMD Serono Research & Development Institute, Inc. Condition: Pancreatic Cancer
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Phase 1 Pancreatic Cancer Trial, Recruiting

NCT07166601
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:

  • (Part 1 – M0324 alone) People with certain advanced or spreading solid tumours that produce high levels of a protein called MUC-1, where standard treatments have stopped working, caused intolerable side effects, or where the treating doctor considers no standard treatment to be appropriate.
  • (Part 2 – M0324 combined with pembrolizumab) People with certain advanced or spreading tumours that produce high levels of MUC-1, who have already received a type of cancer treatment called immune checkpoint inhibitors, whose disease continued to grow or spread during or after that treatment, and where the treating doctor considers no further standard treatment to be appropriate.
  • (Part 3 – M0324 combined with mFOLFIRINOX) People with pancreatic cancer that has spread to other parts of the body and has not yet been treated, where the treating doctor considers a chemotherapy regimen called mFOLFIRINOX to be appropriate.
  • Additional criteria set by the trial protocol may also apply (confirm with trial site).

Who may not be able to join:

  • People with a history of ongoing or severe diarrhoea, inflammatory bowel disease affecting the colon or rectum, or a bowel blockage that has not fully resolved.
  • People who have had another cancer diagnosed within the past 3 years before enrolling in the trial.
  • People with heart or blood pressure conditions that are not well controlled, including uncontrolled high blood pressure, irregular heartbeat, unstable chest pain, a recent heart attack, moderate-to-severe heart failure, or a heart procedure performed within the last 180 days.
  • People whose life expectancy is estimated to be less than 3 months.
  • People who have previously had a Whipple surgical procedure or chemotherapy given after surgery (adjuvant chemotherapy) are not eligible for Part 3 of the trial.
  • Additional exclusion criteria set by 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 22 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
10 October 2025
Est. completion
23 February 2029

Where this trial is recruiting

🇨🇦 Canada 🇯🇵 Japan 🇺🇸 United States

Primary endpoints

Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs); Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs); Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)

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