CML ADVOCATES NETWORK

Clinical Trials

CARDINAL (TERN701-1012) = TERN-701 in Chronic Phase Chronic Myeloid Leukemia [Australia, France, Germany, Italy, South Korea, Spain, USA]

Study title

Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in participants with chronic myeloid leukemia

Scientific title

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

Type of study

Trial after therapy failure or intolerance

Phase

1

Current status

Recruiting

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Other trial ID

CARDINAL, TERN701-1012; ClinicalTrials.gov NCT06163430, EudraCT no. 2023-507677-18

What is the purpose of the study

The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a novel highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase – chronic myeloid leukemia (CP-CML).

What will happen during the study

The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate a range of doses of TERN-701 administered once daily to identify dose levels that are safe, achieve adequate exposure levels, and show evidence of clinical activity measured by hematologic responses and decresase in transcript levels from baseline.

Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of at least 2 recommended dose levels for expansion selected from Part 1. The purpose of Part 2 is to select the optimal therapeutically active dose(s) of TERN-701 for evaluation in subsequent studies in participants with CP-CML.

In both Part 1 and Part 2, participants will receive continuous daily dosing of TERN-701 divided into 28-day cycles.

Key inclusion criteria

This study includes male or female patients who:

  • are aged 18 years or older at the time of signing the informed consent
  • have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
  • have stablished cytopathologically confirmed diagnosis of BCR-ABL1 positive chronic myeloid leukemia in chronic phase (CML-CP) with or without T315l mutation
  • have received treatment with active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
  • are intolerant of asciminib, and do not have resistant/relapsing disease
  • have adequate organ function.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have CML in accelerated or blast phase
  • have been treated with 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).

Further criteria apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

November 2025

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Terns, Inc.

Scientific lead / contact

Principal investigator

Study centers / principal investigators

Australia

Royal Adelaide Hospital
Adelaide
South Australia
Principal Investigator: David Yeung

France

Institut Bergonié
Bordeaux
Principal Investigator: Francois-Xavier Mahon

Centre Hospitalier Lyon Sud
Lyon
Principal Investigator: Marie Balsat

Institut Paoli-Calmettes
Marseille
Principal Investigator: Aude Charbonnier

Centre Hospitalier Universitaire Nantes – Hôtel Dieu
Nantes
Principal Investigator: Viviane Dubruille

Hôpital Saint-Louis
Paris
Principal Investigator: Delphine Rea

Germany

Charite Campus Virchow
Berlin
Principal Investigator: Philipp Le Coutre

Medizinische Hochschule Hannover
Hannover
Principal Investigator: Florian Heidel

Universitätsklinikum Jena
Jena
Principal Investigator: Andreas Hochhaus

Italy

Fondazione IRCCS San Gerardo dei Tintori
Monza
Principal Investigator: Carlo Gambacorti Passerini

Spain

Hospital Clinic de Barcelona
Barcelona
Principal Investigator: Ana Triguero Moreno

Hospital Universitari Vall d’Hebrón
Barcelona
Principal Investigator: Sara Garrido Paniagua

Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas
Principal Investigator: Maria Teresa Gomez Casares

Hospital Universitario 12 de Octubre
Madrid
Principal Investigator: Gonzalo Carreño Gómez-Tarragona

Hospital Universitario Ramón y Cajal
Madrid
Principal Investigator: José Valentín García-Gutiérrez

Hospital Universitario de La Princesa
Madrid
Principal Investigator: Maria del Valle Gomez Garcia de Soria

Hospital Quirónsalud Zaragoza
Zaragoza
Principal Investigator: Maria Pilar Giraldo Castellano

South Korea

Dong-A University Hospital
Busan Gwang’yeogsi
Principal Investigator: Sung-Hyun Kim

Keimyung University Dongsan Hospital
Daegu Gwang’yeogsi
Principal Investigator: Young Rok Do

Uijeongbu Eulji Medical Center
Gyeonggi-do
Principal Investigator: Dong-Wook Kim

Hallym University Sacred Heart Hospital
Gyeonggi-do
Principal Investigator: Dae Young Zang

United States

California

University of California Irvine – Cancer Research Institute
Principal Investigator: Richard Van Etten

Colorado

USOR – Rocky Mountain Cancer Centers – Boulder
Principal Investigator: David Andorsky

Oregon

Oregon Health and Science University
Principal Investigator: Michael Heinrich

Tennessee

SCRI – TriStar Centennial Medical Center
Principal Investigator: Stephen Strickland

Texas

The University of Texas MD Anderson Cancer Center
Principal Investigator: Elias Jabbour

Washington

Fred Hutchinson Cancer Center – Seattle Cancer Care Alliance (SCCA) Location
Principal Investigator: Vivian Oehler