Actively Recruiting
A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Led by Terns, Inc. · Updated on 2026-01-12
180
Participants Needed
54
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes (pharmacokinetics), how the body responds (pharmacodynamics), and effectiveness of TERN-701, a selective inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia who have received prior treatment. This Phase 1/2 trial focuses on participants with treatment challenges such as resistance or intolerance to previous therapies. The study is sponsored by Terns, Inc. and aims to better understand TERN-701's impact in this patient group. The trial has two main parts. Part 1 involves dose escalation where participants receive increasing doses of TERN-701 once daily to determine safe and effective dose levels. Part 2 includes randomized dose expansion cohorts to further assess safety and efficacy at two selected doses from Part 1, and an additional mutation cohort (Part 2m) evaluating a specific 500 mg dose in participants with certain resistance mutations. Treatment is given continuously in 28-day cycles with scheduled clinic visits at specified days during the first cycle and then on Day 1 of subsequent cycles. Participants will be closely monitored through regular visits for safety, tolerability, and response to treatment. Researchers will evaluate dose-limiting toxicities, adverse events, hematologic and molecular responses, and changes in BCR-ABL1 transcript levels over up to three years. Approximately 180 participants are expected to enroll, contributing to comprehensive data collection on TERN-701's performance and safety in this chronic leukemia population.
CONDITIONS
Brief Title
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 years of age or older
- ECOG performance status score of 0 to 2
- Confirmed diagnosis of BCR-ABL1 positive chronic phase chronic myeloid leukemia
- Prior treatment with at least one tyrosine kinase inhibitor with treatment failure, suboptimal response, or intolerance
- Prior treatment with asciminib is allowed
- Adequate organ function as confirmed by local laboratory tests
You will not qualify if you...
- Received systemic anticancer therapy or experimental therapy within 7 days before the first dose of TERN-701
- Previous anticancer therapy completed but with unresolved clinically significant toxicity greater than Grade 2 or baseline
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive TERN-701 orally once daily at assigned dose levels to evaluate safety, tolerability, pharmacokinetics, and efficacy.
Visits occur regularly during treatment cycles (visit frequency as per protocol)
Duration - Up to 3 years
Participants are monitored for safety and efficacy outcomes for up to 3 years after treatment initiation.
Periodic visits during follow-up phase
Trial Site Locations
Total: 54 locations
1
University of Alabama Medicine (UAB Medicine)
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
UC Irvine Health
Orange, California, United States, 92868
Actively Recruiting
4
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80303
Actively Recruiting
5
Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida, United States, 33901
Not Yet Recruiting
6
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States, 34474
Actively Recruiting
7
Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, United States, 33705
Not Yet Recruiting
8
Florida Cancer Specialists - East Region Research Office
West Palm Beach, Florida, United States, 33401
Not Yet Recruiting
9
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States, 10065
Actively Recruiting
11
Atrium Health Levine Cancer Institute
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
12
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Actively Recruiting
13
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
Thomas Jefferson University - Center City (Philadelphia)
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
15
Tristar BMT
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
19
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
20
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
21
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Not Yet Recruiting
22
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
23
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France, 69008
Actively Recruiting
24
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
25
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
26
CHU de Nantes (University Hospital of Nantes) - Hôtel Dieu
Nantes, France, 44093
Actively Recruiting
27
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
28
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
Actively Recruiting
29
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
30
Charité Campus Virchow-Klinikum - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
31
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
32
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
33
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
34
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
35
Klinikum rechts der lsar der Technischen Universität München
München, Germany, 81675
Actively Recruiting
36
Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
37
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
38
Fondazione IRCCS San Gerardo dei Tintori - SC Centro di Ricerca Fase I
Monza, Italy, 20900
Actively Recruiting
39
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Actively Recruiting
40
Auckland City Hospital
Auckland, New Zealand, 1023
Not Yet Recruiting
41
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
42
Uijeorigbu Eulji Medical Center, Eulji University
Uijeongbu-si, Gyeonggi-do, South Korea, 11749
Actively Recruiting
43
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggido, South Korea, 14068
Actively Recruiting
44
Dong-A University hospital
Busan, South Korea, 49201
Actively Recruiting
45
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
Actively Recruiting
46
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
47
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
48
Hospital Universitari Germans Trias i Pujol (ICO Badalona)
Barcelona, Spain, 08916
Actively Recruiting
49
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, Spain, 35010
Actively Recruiting
50
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
51
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
52
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
53
Hospital de Día Quirónsalud Zaragoza
Zaragoza, Spain, 50012
Actively Recruiting
54
Imperial College Healthcare NHS Trust
London, England, United Kingdom, W12 0HS
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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