CML ADVOCATES NETWORK

Clinical Trials

CARDINAL (TERN-701) = TERN-701 in Chronic Myeloid Leukemia [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

Recruitment to start in December 2023

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Other trial ID

TERN701-1012; ClinicalTrials.gov NCT06163430

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 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.

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 end 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

United States

Texas

The University of Texas MD Anderson Cancer Center