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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: Recruiting Phase 1 study of Colorectal Cancer, sponsored by EMD Serono Research & Development Institute.
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 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05464030 shows while recruiting
NCT05464030 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (87% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05464030's enrollment target sits among peer trials
200 147th of 381 higher than 230 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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