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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)
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

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Monash Medical Centre
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ClaytonAustraliaNot yet recruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaNot yet recruiting
Royal Perth Hospital
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PerthAustraliaRecruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Universitat Heidelberg
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MannheimGermanyRecruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital QuirónSalud Zaragoza
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ZaragozaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Paoli-Calmettes
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MarseilleFranceRecruiting
Hospital Hotel Dieu
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NantesFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceRecruiting
Imperial College Healthcare NHS Trust
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LondonUnited KingdomRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
Hallym University Sacred Heart Hospital
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Anyang-siSouth KoreaRecruiting
Dong-A University Hospital
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BusanSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
Uijeorigbu Eulji Medical Center, Eulji University
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Uijeongbu-siSouth KoreaRecruiting
Auckland City Hospital
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AucklandNew ZealandNot yet recruiting
Christchurch Hospital
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ChristchurchNew ZealandRecruiting
Georgia Cancer Center at Augusta University
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AugustaUnited StatesRecruiting
University of Alabama Medicine (UAB Medicine)
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BirminghamUnited StatesRecruiting
Willamette Valley Cancer Institute and Research Center
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EugeneUnited StatesRecruiting
Florida Cancer Specialists - South Region Research Office
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Fort MyersUnited StatesNot yet recruiting
Banner MD Anderson Cancer Center
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GilbertUnited StatesRecruiting
The University of Texas M. D. Anderson Cancer Center
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HoustonUnited StatesRecruiting
Rocky Mountain Cancer Centers,LLP
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Lone TreeUnited StatesRecruiting
TriStar BMT
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NashvilleUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Main Campus
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New YorkUnited StatesRecruiting
Florida Cancer Affiliates - Ocala
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OcalaUnited StatesRecruiting
UC Irvine Health
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OrangeUnited StatesRecruiting
Thomas Jefferson University - Center City (Philadelphia)
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PhiladelphiaUnited StatesRecruiting
Oregon Health Science University
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PortlandUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
Florida Cancer Specialists - North Region Research Office
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St. PetersburgUnited StatesNot yet recruiting
Florida Cancer Specialists - East Region Research Office
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West Palm BeachUnited StatesNot yet recruiting
Atrium Health Levine Cancer Institute
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.