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NCT04868877 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination
A Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Merus B.V..
- Active
- Registry status
- Phase 1
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT04868877: Active Phase 1 study of Colorectal Cancer and Gastric Cancer, sponsored by Merus B.V..
NCT04868877 is a Phase 1 study of Colorectal Cancer and Gastric Cancer that is active but no longer recruiting, run by Merus B.V.. The registered enrollment target is 194 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 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04868877, a Phase 1 study of Colorectal Cancer and Gastric Cancer, is active but no longer recruiting, sponsored by Merus B.V..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.
Primary Outcome
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Chemotherapy
- DRUG MCLA-129
Study Locations (20)
Other
- Institut Jules Bordet - Anderlecht
- Antwerp University Hospital - Edegem
- Clinique de l'Europe - Amiens
- CHU Hopitaux de Bordeaux - Hôpital Saint-André - Bordeaux
- CHU de Lyon - Louis Pradel Hospital - Bron
- Centre Hospitalier Intercommunal de Créteil - Créteil
- Hôpital Albert Calmette - Lille
- L'Institut Paoli - Calmettes - Marseille
- CHU de Nantes - Hôpital Nord Laennec - Nantes
- Marie Wislez - Paris
- Hôpital Bichat - Claude-Bernard - Paris
- Hôpital Européen Georges Pompidou (HEGP) - Paris
- CHU de Poitiers - Poitiers
- Hôpital d'Instruction des Armées Bégin - Saint-Mandé
- Sana Klinikum Offenbach GmbH - Offenbach
California
- University of California, Irvine - Orange
Tennessee
- Sarah Cannon Research Institute - Nashville
Utah
- START Mountain Region - West Valley City
Virginia
- Next Oncology Virginia - Fairfax
Hesse
- Krankenhaus Nordwest - Frankfurt am Main
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What the registry record for NCT04868877 still lists
NCT04868877 is an interventional study that assigns participants to a tested intervention. The registered 194 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 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Osimertinib is the first listed.
NCT04868877 names 20 study sites across 6 states, led by Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04868877 about?
NCT04868877 is a clinical study titled "Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination". A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after re...
What is the current status of trial NCT04868877?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 194 participants. The study started on 2021-04-28. Estimated completion is 2027-03.
What conditions does trial NCT04868877 study?
This clinical trial studies the following conditions: Colorectal Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer Metastatic.
What interventions are being tested in trial NCT04868877?
The interventions under investigation include: Osimertinib (DRUG), Chemotherapy (DRUG), MCLA-129 (DRUG).
Who is sponsoring clinical trial NCT04868877?
This trial is sponsored by Merus B.V., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04868877 being conducted?
This trial has 20 study locations across California, Tennessee, Utah, Virginia, Hesse. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04868877's enrollment target sits among peer trials
194 155th of 381 higher than 227 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.
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