CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT06163430 |
Recruitment Status :
Not yet recruiting
First Posted : December 8, 2023
Last Update Posted : December 8, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia | Drug: TERN-701 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia |
Estimated Study Start Date : | December 13, 2023 |
Estimated Primary Completion Date : | November 30, 2025 |
Estimated Study Completion Date : | May 31, 2026 |
Arm | Intervention/treatment |
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Experimental: Part 1- Dose Level 1 of TERN-701
Dose Level 1 of TERN-701 dosed once daily.
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Drug: TERN-701
TERN-701 orally QD |
Experimental: Part 1- Dose Level 2 of TERN-701
Dose Level 2 of TERN-701 dosed once daily.
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Drug: TERN-701
TERN-701 orally QD |
Experimental: Part 1- Dose Level 3 of TERN-701
Dose Level 3 of TERN-701 dosed once daily.
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Drug: TERN-701
TERN-701 orally QD |
Experimental: Part 1- Dose Level 4 of TERN-701
Dose Level 4 of TERN-701 dosed once daily.
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Drug: TERN-701
TERN-701 orally QD |
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.
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Drug: TERN-701
TERN-701 orally QD |
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.
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Drug: TERN-701
TERN-701 orally QD |
- 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 (RDE) cohorts of TERN-701.
- Part 1 - Serious Adverse Events [ Time Frame: up to 3 years ]Number and percentage of patients with any serious adverse event
- Part 1 - Adverse Events [ Time Frame: up to 3 years ]Number and percentage of patients with any adverse event
- 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.
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 with or without T315l mutation
- Have received treatment with active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
- Participants who are intolerant of asciminib, and do not have resistant/relapsing disease
- Adequate organ function, as assessed by local laboratory
Key Exclusion Criteria:
- CML in accelerated or blast phase
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06163430
Contact: Study Director | 650-486-9623 | clinicaltrials@ternspharma.com |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Responsible Party: | Terns, Inc. |
ClinicalTrials.gov Identifier: | NCT06163430 |
Other Study ID Numbers: |
TERN701-1012 |
First Posted: | December 8, 2023 Key Record Dates |
Last Update Posted: | December 8, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
allosteric inhibitor of BCR-ABL1 CML TERN-701 chronic myeloid leukemia |
T315I T315I mutant CARDINAL HS-10382 |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Hematologic Diseases |
Myeloproliferative Disorders Bone Marrow Diseases Chronic Disease Disease Attributes Pathologic Processes |