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A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
Sponsor: Terns, Inc.
Summary
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort). All participants will receive active trial intervention. Four dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).
Official title: A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-03-26
Completion Date
2030-05-31
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
TERN-701
TERN-701 orally QD
Locations (54)
University of Alabama Medicine (UAB Medicine)
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
UC Irvine Health
Orange, California, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida, United States
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States
Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, United States
Florida Cancer Specialists - East Region Research Office
West Palm Beach, Florida, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Atrium Health Levine Cancer Institute
Winston-Salem, North Carolina, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University - Center City (Philadelphia)
Philadelphia, Pennsylvania, United States
Tristar BMT
Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
Institut Bergonié
Bordeaux, France
Institut Paoli Calmettes
Marseille, France
CHU de Nantes (University Hospital of Nantes) - Hôtel Dieu
Nantes, France
Hôpital Saint Louis
Paris, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Universitätsklinikum Aachen
Aachen, Germany
Charité Campus Virchow-Klinikum - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Klinikum rechts der lsar der Technischen Universität München
München, Germany
Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori - SC Centro di Ricerca Fase I
Monza, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Uijeorigbu Eulji Medical Center, Eulji University
Uijeongbu-si, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, South Korea
Dong-A University hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Germans Trias i Pujol (ICO Badalona)
Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza, Spain
Imperial College Healthcare NHS Trust
London, England, United Kingdom