New antibody M0324 enters first human trials for Hard-to-Treat cancers

NCT ID NCT07166601

Recruiting now Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This early-stage study is testing a new drug called M0324, a bispecific antibody designed to target cancer cells. The trial will look at M0324 alone, with the immunotherapy pembrolizumab, and with chemotherapy in about 77 people with advanced solid tumors that have not responded to other treatments. The main goal is to find a safe dose and check for early signs of effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: M0324 (a bispecific antibody targeting MUC-1 and CD40)
What this could lead to: If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong: This is a very early (Phase 1) study with only 77 participants, so it is primarily testing safety and dosing. The drug may not show enough benefit or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

autosomal dominant medullary cystic kidney disease with or without hyperuricemia neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED SOLID TUMOR

Contacts and locations

Locations

Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
NEXT Oncology
RECRUITING

San Antonio, Texas, 78249, United States
National Cancer Center Hospital
RECRUITING

Chūōku, Japan
Princess Margaret Cancer Centre
RECRUITING

Toronto, Canada
Yale Cancer Center
RECRUITING

New Haven, Connecticut, 06511, United States

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