A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL) (CARDINAL)

January 8, 2026 updated by: Terns, Inc.

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3000
        • Not yet recruiting
        • Peter Maccallum Cancer Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonie
      • Marseille, France, 13273
        • Recruiting
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes (University Hospital of Nantes) - Hôtel Dieu
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint Louis
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon-Sud
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Recruiting
        • Centre Leon Berard
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Universitätsklinikum Aachen
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Campus Virchow-Klinikum - Universitätsmedizin Berlin
      • Frankfurt am Main, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der lsar der Technischen Universität München
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Monza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
      • Monza, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - SC Centro di Ricerca Fase I
  • New Zealand
      • Auckland, New Zealand, 1023
        • Not yet recruiting
        • Auckland City Hospital
      • Christchurch, New Zealand, 8011
        • Recruiting
        • Christchurch Hospital
  • South Korea
      • Busan, South Korea, 49201
        • Recruiting
        • Dong-A University Hospital
      • Daegu, South Korea, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Uijeongbu-si, Gyeonggi-do, South Korea, 11749
        • Recruiting
        • Uijeorigbu Eulji Medical Center, Eulji University
    • Gyeonggido
      • Anyang-si, Gyeonggido, South Korea, 14068
        • Recruiting
        • Hallym University Sacred Heart Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol (ICO Badalona)
      • Las Palmas, Spain, 35010
        • Recruiting
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
      • Zaragoza, Spain, 50012
        • Recruiting
        • Hospital de Día Quirónsalud Zaragoza
  • United Kingdom
    • England
      • London, England, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama Medicine (UAB Medicine)
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
    • Colorado
      • Lone Tree, Colorado, United States, 80303
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Not yet recruiting
        • Florida Cancer Specialists - South Region Research Office
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Florida Cancer Affiliates - Ocala
      • St. Petersburg, Florida, United States, 33705
        • Not yet recruiting
        • Florida Cancer Specialists - North Region Research Office
      • West Palm Beach, Florida, United States, 33401
        • Not yet recruiting
        • Florida Cancer Specialists - East Region Research Office
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Main Campus
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Atrium Health Levine Cancer Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Center City (Philadelphia)
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tristar BMT
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male or female participants ≥ 18 years of age at the time of signing the informed consent
  • Have an ECOG performance status score of 0 to 2
  • Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
  • Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance
  • Prior treatment with asciminib is allowed
  • Adequate organ function, as assessed by local laboratory

Key Exclusion Criteria:

  • Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
  • Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1- Dose Level 1 (160 mg) of TERN-701
Dose Level 1 of TERN-701 dosed once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 1- Dose Level 2 (320 mg) of TERN-701
Dose Level 2 of TERN-701 dosed once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 1- Dose Level 3 (400 mg) of TERN-701
Dose Level 3 of TERN-701 dosed once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 1- Dose Level 4 (500 mg) of TERN-701
Dose Level 4 of TERN-701 dosed once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 2 - Dose 1 (320 mg)
Dose 1 was selected based on the totality of safety, PK, PD and efficacy data from Part 1. TERN-701 administered once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 2 - Dose 2 (500 mg)
Dose 2 was selected based on the totality of safety, PK, PD and efficacy data from Part 1. TERN-701 administered once daily.
Drug: TERN-701
TERN-701 orally QD
Experimental: Part 2m - 500 mg Dose
Dose for Part 2m was selected based on the totality of safety, PK, PD and efficacy data from Part 1 and nonclinical data. TERN-701 is administered once daily.
Drug: TERN-701
TERN-701 orally QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 - Serious Adverse Events
Time Frame: up to 3 years
Number and percentage of patients with any serious adverse event
up to 3 years
Part 1 - Adverse Events
Time Frame: up to 3 years
Number and percentage of patients with any adverse event
up to 3 years
Part 2- Complete Hematologic Response (CHR)
Time Frame: up to 3 years
CHR Defined by ELN 2020 criteria in participants who are not in CHR at baseline.
up to 3 years
Part 2: Molecular response (MR)
Time Frame: up to 3 years
MR defined by ELN 2020 criteria measured by quantitative polymerase chain reaction of BCR-ABL transcript levels.
up to 3 years
Part 2 - Best categorical shift in BCR-ABL1 transcript levels from baseline
Time Frame: up to 3 years
The best categorical molecular response shift on treatment relative to baseline
up to 3 years
Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment
Time Frame: First cycle is 28 days
Determination of the Maximum Tolerated Dose (MTD) and recommended doses for expansion cohorts of TERN-701.
First cycle is 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terns, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2024

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERN701-1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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