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

Sponsor: Terns, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06163430

This Phase 1/2 study assesses TERN-701, an oral drug, in CP-CML patients with prior TKI treatment. Participants, aged 18+, must have BCR-ABL1 positive CML and adequate organ function. The trial includes dose escalation and expansion phases, with continuous daily dosing. Eligibility requires prior treatment failure or intolerance, and allows previous asciminib use.

Patient Parameters

Parameter	Options

Program Overview

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).

Eligibility Criteria

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)

Locations

FACILITY	ZIP	CITY	STATE
University of Alabama Medicine (UAB Medicine)	35233	Birmingham	Alabama
Banner MD Anderson Cancer Center	85234	Gilbert	Arizona
UC Irvine Health	92868	Orange	California
Rocky Mountain Cancer Centers, LLP	80303	Lone Tree	Colorado
Florida Cancer Specialists - South Region Research Office	33901	Fort Myers	Florida
Florida Cancer Affiliates - Ocala	34474	Ocala	Florida
Florida Cancer Specialists - North Region Research Office	33705	St. Petersburg	Florida
Florida Cancer Specialists - East Region Research Office	33401	West Palm Beach	Florida
Georgia Cancer Center at Augusta University	30912	Augusta	Georgia
Memorial Sloan Kettering Cancer Center - Main Campus	10065	New York	New York

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