Active, not recruitingPhase IEN originalColorectal cancer

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

This trial is no longer recruiting — here are similar active trials

Matched by cancer type/biomarker, currently recruiting.

RecruitingUnknown phase🇵🇱 PolandColorectal cancerMetastatic / advanced

Metastatic colorectal cancer or mCRC is a cancer that starts in the parts of the large intestine (the colon or rectum) and has already spread to other parts of the body. This cancer can be hard to treat because it can behave differently from one person to another. Over time, treatments may stop working, and side effects can build up. In later treatment stages, there are only a few standard medicine options available. Because of this, studies often look at both how long people live and how treatment affects quality of life. The main aim of this study is to see how long adults in Poland with mCRC live without their cancer getting worse (progression-free survival or PFS) when they receive fruquintinib after at least two previous treatments. Fruquintinib (TAK 113) is a medicine taken by mouth that is designed to slow tumor growth. Other aim is to find out how long adults in Poland with mCRC live while being treated with fruquintinib (overall survival or OS). The study also wants to record how fruquintinib is used in routine care in adults with mCRC in Poland (for example when treatment starts, changes in doses, and how long treatment continues). Another aim is to learn about people with mCRC, such as their medical history and past treatment as well as their quality of life while they are in the study. The study will look at data already existing in the participants' medical charts.

The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.

RecruitingPhase II🇵🇱 PolandColorectal cancerMetastatic / advanced

Researchers are looking for a better way to treat people with advanced colorectal cancer. Colorectal cancer (cancer of the colon or rectum) is one of the most common cancers worldwide. Treatments include surgery, chemotherapy, radiotherapy, and immunotherapy; however, these treatments do not work for everyone, may cause serious adverse events or may stop working eventually. New treatments and treatment combinations are needed, especially for cancers that cannot be removed with surgery or that have spread to other parts of the body (called advanced or metastatic cancer). Cells normally repair themselves when mistakes happen as they divide. But in some people with cancer, the repair system does not work properly because of a problem called dMMR (deficient mismatch repair). As a result, mistakes build up in the cell's DNA, leading to a condition called MSI (microsatellite instability). Over time, these changes can cause cells to grow and behave abnormally, contributing to the development and growth of cancer. To survive, some cancer cells with dMMR or MSI rely on a protein called Werner helicase. This protein helps repair some of the DNA damage allowing them to keep growing. Because these cancer cells depend more on Werner helicase than healthy cells, blocking this protein may help stop cancer cells from surviving while having less effect on healthy cells. The study drug, VVD-133214, is designed to block the Werner helicase protein. Blocking this protein may help stop cancer cells from growing, while causing less harm to healthy cells. VVD-133214 is being studied in combination with pembrolizumab, an approved immunotherapy that helps the immune system recognize and attack cancer cells. This study will test the combination of VVD-133214 and pembrolizumab in people with advanced colorectal cancer with MSI and/or dMMR who have not yet received treatment for their advanced disease. The study aims to find the best dose of VVD-133214 in combination with pembrolizumab and to test whether the combination is more effective than pembrolizumab alone. Participants will receive treatment with VVD-133214 for as long as it can help them and does not cause serious adverse events. Treatment with pembrolizumab will stop after two years. Participants can also stop treatment at any time. During the study, participants will have regular visits with the study doctor for tests, scans, and check-ups. These visits help check how well the cancer is responding to the treatment and monitor the participants' health. The study will also monitor adverse events, which are any new or worsening medical problems that can happen during the study. Doctors record all adverse events, irrespective of whether the study doctor believes they are related to the study treatments, to help ensure participants' safety throughout the study. After stopping treatment, participants will return for follow-up visits: 30 days after their last dose of VVD-133214 and/or 100 days after their last dose of pembrolizumab. After that, participants will have long-term follow-up visits every 90 days for as long as they agree to continue participating in follow-up.

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Osoby z rakiem jelita grubego (w zaawansowanym lub rozsianym stadium), które nie tolerują lub nie reagują na dotychczasowe leczenie.
  • •Osoby w dobrym stanie ogólnym (zdolne do normalnej aktywności)
  • •Osoby z odpowiednimi wynikami badań krwi, wątroby i nerek.

✗ Disqualifies

  • •Osoby z innymi nowotworami w ciągu ostatnich 3 lat (z pewnymi wyjątkami, np. rak skóry).
  • •Osoby z przerzutami do mózgu, które nie zostały wcześniej skutecznie wyleczone i nie są stabilne.
  • •Osoby z aktywnymi chorobami zapalnymi jelit lub niedrożnością jelit.
  • •Osoby z problemami kardiologicznymi (np. po zawale serca, z niewydolnością serca) w ciągu ostatnich 6 miesięcy.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 30, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (35)

California Cancer Associates for Research & Excellence, Inc.

Encinitas, United States

California Cancer Associates for Research & Excellence, Inc.

Fresno, United States

Rhode Island Hospital

Providence, United States

Mary Crowley Cancer Research

Dallas, United States

MD Anderson Cancer Center - Oncology

Houston, United States

NEXT Oncology

San Antonio, United States

The Ottawa Hospital Cancer Centre

Ottawa, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Canada

National Cancer Center Hospital - Dept of Gastroenterology

Chūōku, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

Saitama Cancer Center

Kitaadachi-gun, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Kindai University Hospital

Osakasayama-shi, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

Kanagawa Cancer Center

Yokohama, Japan

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital HM Nou Delfos

Barcelona, Spain

Hospital Universitari Vall d'Hebron - VHIR

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Quironsalud Madrid - NEXT Oncology

Madrid, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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