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NCT Number: NCT06163430

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)

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).

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Key information

Conditions

Chronic Myeloid Leukemia, Chronic Phase Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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)

Treatment and study plan

TERN-701

Drug

TERN-701 orally QD

Primary outcomes

  1. Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment

    Time frame: First cycle is 28 days

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

  2. Part 1 - Serious Adverse Events

    Time frame: up to 3 years

    Number and percentage of patients with any serious adverse event

  3. Part 1 - Adverse Events

    Time frame: up to 3 years

    Number and percentage of patients with any adverse event

  4. Part 2- Complete Hematologic Response (CHR)

    Time frame: up to 3 years

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

  5. Part 2: Molecular response (MR)

    Time frame: up to 3 years

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

  6. Part 2 - Best categorical shift in BCR-ABL1 transcript levels from baseline

    Time frame: up to 3 years

    The best categorical molecular response shift on treatment relative to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

650-525-5535

Sponsors and collaborators

Lead sponsor

Terns, Inc.

Industry

Registry information

Official study title

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia

Acronym: CARDINAL

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Dec 8, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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