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 how well it works, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a this drug alone(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).
Official registry: https://clinicaltrials.gov/study/NCT07166601 · EMD Serono Research & Development Institute, Inc. · enrollment listed as 77
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are M0324, M0324, or Pembrolizumab. The registry lists allocation as randomized. 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 how well it works, pharmacokinetics (PK), and pharmacodynamics (PD).
They plan to enroll about 77 people at 5 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors
Interventions: M0324, M0324, Pembrolizumab, mFOLFIRINOX
Primary outcome (registry wording): Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
US Medical Information
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 2 sites outside the US on the same record
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary