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

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06163430
• Other study ID #: TERN701-1012
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 13, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: Terns, Inc.
• Contact: Study Director
• Phone: 650-486-9623
• Email: clinicaltrials[@]ternspharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 31, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• TERN-701
TERN-701 orally QD

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Terns, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment	Determination of the Maximum Tolerated Dose (MTD) and recommended doses for expansion (RDE) cohorts of TERN-701.	First cycle is 28 days
Primary	Part 1 - Serious Adverse Events	Number and percentage of patients with any serious adverse event	up to 3 years
Primary	Part 1 - Adverse Events	Number and percentage of patients with any adverse event	up to 3 years
Primary	Part 2- Complete Hematologic Response (CHR)	CHR Defined by ELN 2020 criteria in participants who are not in CHR at baseline.	up to 3 years
Primary	Part 2: Molecular response (MR)	MR defined by ELN 2020 criteria measured by quantitative polymerase chain reaction of BCR-ABL transcript levels.	up to 3 years
Primary	Part 2 - Best categorical shift in BCR-ABL1 transcript levels from baseline	The best categorical molecular response shift on treatment relative to baseline	up to 3 years