Study on Anti-CEACAM5 ADC M9140 for Advanced Solid Tumors (PROCEADE PanTumor)

Sponsor: EMD Serono Research & Development Institute, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06710132

This clinical trial is exploring a new treatment called M9140 for various advanced cancers that express a specific protein known as CEACAM5. The study aims to evaluate how well the treatment works, its safety, and how the body processes it, either alone or in combination with other treatments.

Patient Parameters

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Program Overview

The PROCEADE PanTumor study is testing a new drug, M9140, in adults with advanced cancers that have a protein called CEACAM5. The study will look at how effective and safe M9140 is, both on its own and with other treatments. There are three parts to this study, each focusing on a different type of cancer: advanced gastric cancer, non-small cell lung cancer, and pancreatic cancer.

Description

This study is divided into three parts, each focusing on a different type of cancer:

Gastric Cancer (Substudy GC): Participants will be in the study for about 10 months. This includes a 28-day screening period, a one-hour infusion on the first day of each treatment cycle, and a follow-up visit about a month after the last dose.
Non-Small Cell Lung Cancer (Substudy NSCLC): Participants will be in the study for about 12 months, with a similar schedule to the gastric cancer substudy.
Pancreatic Cancer (Substudy PDAC): Participants will be in the study for about 8 months, following the same schedule as the other substudies.

Each substudy will assess the treatment's effectiveness and safety in patients with advanced forms of these cancers.

Eligibility Criteria

Inclusion Criteria

Able to provide informed consent.
Good overall health with a performance status score of 0 or 1.
Adequate blood, liver, and kidney function.
At least one measurable tumor.

Substudy GC:

Advanced or metastatic gastric cancer that has not responded to previous treatments.
Specific levels of CEACAM5 protein in the tumor.

Substudy NSCLC:

Advanced or metastatic non-small cell lung cancer that has not responded to previous treatments.
Specific levels of CEACAM5 protein in the tumor.

Substudy PDAC:

Advanced or metastatic pancreatic cancer that has not responded to previous treatments.
High levels of CEACAM5 protein in the tumor.

Exclusion Criteria

History of another cancer within the last 3 years, except for certain skin cancers or other low-risk cancers.
Known brain metastases unless treated and stable.
Severe diarrhea or bowel disease.
Recent heart problems or stroke.

Substudy GC:

Previous treatment with irinotecan.

Substudy NSCLC:

Previous treatment with irinotecan.

Locations

FACILITY	ZIP	CITY	STATE
NEXT Virginia	22031	Fairfax	Virginia

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