M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Część 1: Zaawansowany nowotwór, który nie odpowiada na standardowe leczenie lub pacjent go nie toleruje
  • Część 2: Zaawansowany nowotwór, pacjent wcześniej otrzymywał immunoterapię, ale choroba się pogorszyła
  • Część 3: Nieoperowany rak trzustki przydatny do leczenia chemioterapią mFOLFIRINOX

✗ Disqualifies

  • Przewlekła biegunka lub choroby zapalne jelita grubego
  • Historia innego nowotworu złośliwego w ciągu ostatnich 3 lat
  • Nieskontrolowane wysokie ciśnienie tętnicze, poważne problemy z sercem lub zawał w ostatnich 6 miesiącach
  • Spodziewana długość przeżycia poniżej 3 miesięcy

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

Yale University School of Medicine

New Haven, United States

Icahn School of Medicine at Mount Sinai

New York, United States

NEXT Oncology

San Antonio, United States

Princess Margaret Cancer Centre

Toronto, Canada

National Cancer Center Hospital

Chūōku, Japan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/18/2026.

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