NCT06163430RecruitingPhase 1/2
A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)
A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer. The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- First submitted
- 8 Nov 2023
- Start date
- 26 Mar 2024
- Primary completion date
- 30 Nov 2029
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT06163430
- EU CT number
- 2023-507677-18-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 330
- From 26 Mar 2024 to the primary completion date, 30 Nov 2029
- 53 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of MK-4208/TERN-701
- Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)
Who the study is looking for
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Have an established cytopathologically confirmed diagnosis of breakpoint cluster region::Abelson (BCR-ABL1) positive Chronic Myeloid Leukemia (CML) in Chronic Phase
- Have received treatment with at least one prior tyrosine kinase inhibitor (TKI) and have treatment failure, suboptimal response, or treatment intolerance
- Prior treatment with asciminib is allowed
- Adequate organ function, as assessed by local laboratory
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (53)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Not yet recruiting |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitat Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital QuirónSalud Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang-si | South Korea | Recruiting |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Uijeorigbu Eulji Medical Center, Eulji University Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Not yet recruiting |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Georgia Cancer Center at Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| University of Alabama Medicine (UAB Medicine) Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Willamette Valley Cancer Institute and Research Center Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Florida Cancer Specialists - South Region Research Office Coordinator of this site? Confirm its status | Fort Myers | United States | Not yet recruiting |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| The University of Texas M. D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Rocky Mountain Cancer Centers,LLP Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| TriStar BMT Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Main Campus Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Florida Cancer Affiliates - Ocala Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Thomas Jefferson University - Center City (Philadelphia) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Florida Cancer Specialists - North Region Research Office Coordinator of this site? Confirm its status | St. Petersburg | United States | Not yet recruiting |
| Florida Cancer Specialists - East Region Research Office Coordinator of this site? Confirm its status | West Palm Beach | United States | Not yet recruiting |
| Atrium Health Levine Cancer Institute Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.