Actively Recruiting
A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
Led by Terns, Inc. · Updated on 2026-01-12
180
Participants Needed
54
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 at signing informed consent
- ECOG performance status score between 0 and 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 allowed
- Adequate organ function confirmed by local laboratory tests
You will not qualify if you...
- Received systemic antineoplastic therapy or other experimental therapy within 7 days before starting TERN-701
- Completed previous anticancer therapy but still have clinically significant side effects above grade 2 or baseline
AI-Screening
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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
CONTACT
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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