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

ClinicalTrials.gov ID: NCT06163430

Public ClinicalTrials.gov record NCT06163430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:25 AM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06163430
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); Industry
Enrollment: 180 participants

Conditions and interventions

Conditions

Interventions

TERN-701 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 25, 2024
Primary completion: Nov 29, 2029
Completion: May 30, 2030
Last update posted: Jan 11, 2026

2024 – 2030

United States locations

U.S. sites: 18
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
University of Alabama Medicine (UAB Medicine)	Birmingham	Alabama	35233	Recruiting
Banner MD Anderson Cancer Center	Gilbert	Arizona	85234	Recruiting
UC Irvine Health	Orange	California	92868	Recruiting
Rocky Mountain Cancer Centers, LLP	Lone Tree	Colorado	80303	Recruiting
Florida Cancer Specialists - South Region Research Office	Fort Myers	Florida	33901	Not yet recruiting
Florida Cancer Affiliates - Ocala	Ocala	Florida	34474	Recruiting
Florida Cancer Specialists - North Region Research Office	St. Petersburg	Florida	33705	Not yet recruiting
Florida Cancer Specialists - East Region Research Office	West Palm Beach	Florida	33401	Not yet recruiting
Georgia Cancer Center at Augusta University	Augusta	Georgia	30912	Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus	New York	New York	10065	Recruiting
Atrium Health Levine Cancer Institute	Winston-Salem	North Carolina	27103	Recruiting
Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	97401	Recruiting
Oregon Health & Science University	Portland	Oregon	97239	Recruiting
Thomas Jefferson University - Center City (Philadelphia)	Philadelphia	Pennsylvania	19107	Recruiting
Tristar BMT	Nashville	Tennessee	37203	Recruiting
The University of Texas M.D. Anderson Cancer Center	Houston	Texas	77030	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	84112	Recruiting
Fred Hutchinson Cancer Center	Seattle	Washington	98109	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06163430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 11, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06163430 live on ClinicalTrials.gov.

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