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

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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). 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 at least 2 recommended dose levels for expansion selected from Part 1. In both Part 1 and Part 2, participants will receive continuous 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, C1D8, C1D15, and C1D16, followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 100 participants could be enrolled in this trial, including up to 60 participants in Part 1 (dose escalation), including optional backfill cohorts, and approximately 40 participants in Part 2 (randomized dose expansion). All participants will receive active trial intervention. At least 4 dose-level cohorts may be evaluated in Part 1; at least 2 dose levels may be evaluated in Part 2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance

• Prior treatment with asciminib may be allowed

• Adequate organ function, as assessed by local laboratory

Locations
United States
California
UC Irvine Health
RECRUITING
Orange
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
Georgia
Georgia Cancer Center at Augusta University
RECRUITING
Augusta
New York
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING
New York
Oregon
Willamette Valley Cancer Institute and Research Center
RECRUITING
Eugene
Oregon Health & Science University
RECRUITING
Portland
Tennessee
Tristar BMT
RECRUITING
Nashville
Texas
The University of Texas M.D. Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Royal Perth Hospital
RECRUITING
Perth
France
Institut Bergonié
RECRUITING
Bordeaux
Institut Paoli Calmettes
RECRUITING
Marseille
CHU de Nantes (University Hospital of Nantes) - Hôtel Dieu
RECRUITING
Nantes
Hôpital Saint Louis
RECRUITING
Paris
Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Medizinische Hochschule Hannover
RECRUITING
Hanover
Apotheke des Universitätsklinikums Jena
RECRUITING
Jena
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Mannheim
RECRUITING
Mannheim
Klinikum rechts der lsar der Technischen Universität München
RECRUITING
München
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
RECRUITING
Bologna
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - SC Farmacia
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Fondazione IRCCS San Gerardo dei Tintori - SC Centro di Ricerca Fase I
RECRUITING
Monza
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Dong-A University hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Uijeorigbu Eulji Medical Center, Eulji University
RECRUITING
Uijeongbu-si
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Germans Trias i Pujol (ICO Badalona)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebrón
RECRUITING
Barcelona
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital de Día Quirónsalud Zaragoza
RECRUITING
Zaragoza
Hospital Quirónsalud Zaragoza
RECRUITING
Zaragoza
Contact Information
Primary
Study Director
clinicaltrials@ternspharma.com
650-525-5535
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 100
Treatments
Experimental: Part 1- Dose Level 1 of TERN-701
Dose Level 1 of TERN-701 dosed once daily.
Experimental: Part 1- Dose Level 2 of TERN-701
Dose Level 2 of TERN-701 dosed once daily.
Experimental: Part 1- Dose Level 3 of TERN-701
Dose Level 3 of TERN-701 dosed once daily.
Experimental: Part 1- Dose Level 4 of TERN-701
Dose Level 4 of TERN-701 dosed once daily.
Experimental: Part 2 - Dose 1
Dose 1 will be selected from Part 1 based on the totality of safety, PK, PD and efficacy data from Part 1 will be selected. TERN-701 is planned to be administered once daily.
Experimental: Part 2 - Dose 2
Dose 2 will be selected from Part 1 based on the totality of safety, PK, PD and efficacy data from Part 1 will be selected. TERN-701 is planned to be administered once daily.
Sponsors
Leads: Terns, Inc.

This content was sourced from clinicaltrials.gov