A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TERN-701.
- Who it may be relevant to
- Registry conditions: Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, France, Germany, Italy +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Drug TERN-701
TERN-701 orally QD
Primary outcome measures
- Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment [Time frame: First cycle is 28 days]
- Part 1 - Serious Adverse Events [Time frame: up to 3 years]
- Part 1 - Adverse Events [Time frame: up to 3 years]
- Part 2- Complete Hematologic Response (CHR) [Time frame: up to 3 years]
- Part 2: Molecular response (MR) [Time frame: up to 3 years]
- Part 2 - Best categorical shift in BCR-ABL1 transcript levels from baseline [Time frame: up to 3 years]
Eligibility criteria
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
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- University of Alabama Medicine (UAB Medicine) — Birmingham
- Banner MD Anderson Cancer Center — Gilbert
- UC Irvine Health — Orange
- Rocky Mountain Cancer Centers, LLP — Lone Tree
- Florida Cancer Specialists - South Region Research Office — Fort Myers
- Florida Cancer Affiliates - Ocala — Ocala
- Florida Cancer Specialists - North Region Research Office — St. Petersburg
- Florida Cancer Specialists - East Region Research Office — West Palm Beach
- … and 10 more centers
Spain · 8 centers
- Hospital Universitari Vall d'Hebrón — Barcelona
- Hospital Clínic de Barcelona — Barcelona
- Hospital Universitari Germans Trias i Pujol (ICO Badalona) — Barcelona
- Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas
- Hospital Universitario de La Princesa — Madrid
- Hospital Universitario Ramón y Cajal — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital de Día Quirónsalud Zaragoza — Zaragoza
Germany · 7 centers
- Universitätsklinikum Aachen — Aachen
- Charité Campus Virchow-Klinikum - Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Frankfurt — Frankfurt am Main
- Medizinische Hochschule Hannover — Hanover
- Universitätsklinikum Jena — Jena
- Universitätsklinikum Mannheim — Mannheim
- Klinikum rechts der lsar der Technischen Universität München — München
France · 6 centers
- Centre Léon Bérard — Lyon
- Institut Bergonié — Bordeaux
- Institut Paoli Calmettes — Marseille
- CHU de Nantes (University Hospital of Nantes) - Hôtel Dieu — Nantes
- Hôpital Saint Louis — Paris
- Centre Hospitalier Lyon-Sud — Pierre-Bénite
Australia · 4 centers
- Royal Adelaide Hospital — Adelaide
- Monash Medical Centre — Clayton
- Peter MacCallum Cancer Centre — Melbourne
- Royal Perth Hospital — Perth
Italy · 4 centers
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola — Bologna
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
- Fondazione IRCCS San Gerardo dei Tintori - SC Centro di Ricerca Fase I — Monza
- Fondazione IRCCS San Gerardo dei Tintori — Monza
South Korea · 4 centers
- Uijeorigbu Eulji Medical Center, Eulji University — Uijeongbu-si
- Hallym University Sacred Heart Hospital — Anyang-si
- Dong-A University hospital — Busan
- Keimyung University Dongsan Hospital — Daegu
New Zealand · 2 centers
- Auckland City Hospital — Auckland
- Christchurch Hospital — Christchurch
United Kingdom · 1 center
- Imperial College Healthcare NHS Trust — London
Identifiers
NCT: NCT06163430 · TERN701-1012