Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Dose Level 1 of TERN-701 dosed once daily.

Dose Level 2 of TERN-701 dosed once daily.

Dose Level 3 of TERN-701 dosed once daily.

Dose Level 4 of TERN-701 dosed once daily.

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.

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.

TERN-701

Study Director

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 60 to 80 participants could be enrolled in this trial, including approximately 24 to 36 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.

Up to 4 dose-level cohorts may be evaluated in Part 1; at least 2 dose levels may be evaluated in Part 2.

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

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

Determination of the Maximum Tolerated Dose (MTD) and recommended doses for expansion (RDE) cohorts of TERN-701.

Number and percentage of patients with any serious adverse event

Number and percentage of patients with any adverse event

CHR Defined by ELN 2020 criteria in participants who are not in CHR at baseline.

MR defined by ELN 2020 criteria measured by quantitative polymerase chain reaction of BCR-ABL transcript levels.

The best categorical molecular response shift on treatment relative to baseline

Terns, Inc.

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

ELVN-001 administered in 3+3 dose escalation

ELVN-001 administered at the recommended dose in CML without T315I mutations

ELVN-001 administered at a different recommended dose in CML without T315I mutations

ELVN-001 administered at the recommended dose for CML with T315I mutation

ELVN-001

Study Contact

Michael Mauro, MD

Michael Heinrich, MD

Koji Sasaki, MD

Naranie Shanmuganathan, Dr

Gabriel Etienne, Dr

Valerie Coiteux, Dr

Pascal Turlure, Dr

Franck Nicolini, Dr

Marie Balsat, Dr

Martina Crysandt, Dr Med

Philipp Le Coutre, Dr

Fabian Lang, Dr Med

Andreas Hochhaus, Prof Dr

Susanne Saussele, Prof Dr

Dong-Wook Kim, Dr

Patricia Velez Tenza, Dr

Maria Raquel de Paz Arias, Dr

Luis Felipe Casado Montero, Dr

Elvira Mora Castera, Dr

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who do not tolerate or benefit from available TKIs.

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

DLTs will be used to support that the recommended doses for expansion are \</= MTD

Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable

Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

Adverse events will be used to support that the dose(s) evaluated in expansion is tolerable

Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in expansion is tolerable

Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in expansion is tolerable

PK parameter based on measurement of drug concentration in blood over time

PK parameter based on measurement of drug concentration in blood

PK parameter which is the time at which the highest concentration of drug in the blood is measured

PK parameter based on the measurement of the drug concentration that is at the lowest level once steady state has been achieved.

measured by quantitative polymerase chain reaction of BCR-ABL transcript levels

Time from first molecular response (as measured by quantitative polymerase chain reaction of BCR-ABL transcript levels) to loss of response or discontinuation of study drug

The proportion of patients who achieve a CHR who are not in CHR at baseline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia	NCT06163430	Chronic Myeloid... Chronic Myeloid...	TERN-701	18 Years -	Terns, Inc.
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia	NCT06163430	Chronic Myeloid... Chronic Myeloid...	TERN-701	18 Years -	Terns, Inc.
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia	NCT05304377	Chronic Myeloid...	ELVN-001	18 Years -	Enliven Therapeutics

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