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NCT05464030 · ClinicalTrials.gov registry record · Phase 1
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
A Phase 1 study of Colorectal Cancer, sponsored by EMD Serono Research & Development Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05464030 is a Phase 1 study of Colorectal Cancer that is actively recruiting participants, run by EMD Serono Research & Development Institute. The registered enrollment target is 200 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT05464030, a Phase 1 study of Colorectal Cancer, is actively recruiting participants, sponsored by EMD Serono Research & Development Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- DRUG 5-fluorouracil (5-FU)
- DRUG M9140
Study Locations (20)
Other
- The Ottawa Hospital Cancer Centre - Ottawa
- University Health Network - Princess Margaret Cancer Centre - Toronto
- National Cancer Center Hospital - Dept of Gastroenterology - Chūōku
- National Cancer Center Hospital East - Kashiwa-shi
- Saitama Cancer Center - Kitaadachi-gun
- Cancer Institute Hospital of JFCR - Kōtoku
- Aichi Cancer Center Hospital - Nagoya
- Kindai University Hospital - Osakasayama-shi
- Shizuoka Cancer Center - Sunto-gun
- Kanagawa Cancer Center - Yokohama
- Kyungpook National University Chilgok Hospital - Daegu
- National Cancer Center - Goyang-si
- Seoul National University Bundang Hospital - Seongnam
- Asan Medical Center - Seoul
Texas
- Mary Crowley Cancer Research - Dallas
- MD Anderson Cancer Center - Oncology - Houston
- NEXT Oncology - San Antonio
California
- California Cancer Associates for Research & Excellence, Inc. - Encinitas
- California Cancer Associates for Research & Excellence, Inc. - Fresno
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-08-04 |
| Est. Completion | 2027-02-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05464030
The ClinicalTrials.gov registry entry for NCT05464030 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (87% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT05464030 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05464030 about?
NCT05464030 is a clinical study titled "Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)". The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per par...
What is the current status of trial NCT05464030?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2022-08-04. Estimated completion is 2027-02-26.
What conditions does trial NCT05464030 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT05464030?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), 5-fluorouracil (5-FU) (DRUG), M9140 (DRUG).
Who is sponsoring clinical trial NCT05464030?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464030 being conducted?
This trial has 20 study locations across California, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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