Recruiting
Phase 1
Phase 2

TERN-701

Sponsor:

Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Code:

NCT06163430

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Myeloid Leukemia, Chronic Phase

Chronic Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MK-4208

Study Details

Brief summary:

Researchers are looking for a new way to treat a blood cancer called chronic myeloid leukemia (CML). Researchers want to learn if MK-4208 (Tern-701) can treat this type of blood cancer.

The goal of this study is to learn about the safety of different doses (amounts) of MK-4208 (Tern-701) and if people tolerate them. Researchers also want to find the highest dose of MK-4208 (Tern-701) that people can tolerate and may work to treat blood cancer.

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Myeloid Leukemia, Chronic Phase

Chronic Myeloid Leukemia

Study ID

NCT06163430

Start date

Mar 26, 2024

Status verified date

Oct, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Inclusion Criteria include but are not limited to:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Have an established cytopathologically confirmed diagnosis of breakpoint cluster region::Abelson (BCR-ABL1) positive Chronic Myeloid Leukemia (CML) in Chronic Phase
  • Have received treatment with at least one prior tyrosine kinase inhibitor (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:

Exclusion criteria include but are not limited to:

  • Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of MK-4208/TERN-701
  • Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 - MK-4208 160 mg once daily (QD)

Participants receive MK-4208 160 mg orally QD.

experimental: Part 1- MK-4208 320 mg QD

Participants receive MK-4208 320 mg orally QD.

experimental: Part 1- MK-4208 400 mg QD

Participants receive MK-4208 400 mg orally QD.

experimental: Part 1- MK-4208 500 mg QD

Participants receive MK-4208 500 mg orally QD.

experimental: Part 2 - MK-4208 320 mg QD

Participants receive MK4208 320 mg orally QD.

experimental: Part 2 - MK-4208 500 mg QD

Participants receive MK4208 500 mg orally QD.

experimental: Part 2m - MK-4208 320 mg twice per day (BID)

Participants receive MK4208 320 mg orally BID.

experimental: Part 2m - MK-4208 500 mg QD

Participants receive MK-4208 500 mg orally QD.

experimental: Part 2m - MK4208 500 mg BID

Participants receive MK4208 500 mg orally BID.

experimental: Part 3 - MK-4208 500 mg QD

Participants receive MK-4208 500 mg QD

Interventions

MK-4208

40 mg and 100 mg oral tablets

Primary outcome measure

  • Part 1: Incidence of Dose Limiting Toxicities (DLTs) During the First Cycle of Intervention [ Time Frame: Up to 28 days ]
  • Parts 1, 2m and 3: Number of Participants with at Least One AE [ Time Frame: Up to 3 years ]
  • Parts 1, 2m and 3: Number of Participants with at Least One Serious Adverse Event (SAE) [ Time Frame: Up to 3 years ]
  • Parts 1, 2m and 3: Number of Participants who Discontinued Study Intervention Due to an AE [ Time Frame: Up to 3 years ]
  • Parts 2, 2m and 3: Number of Participants with a Complete Hematologic Response (CHR) [ Time Frame: Baseline and up to 3 years ]
  • Parts 2, 2m and 3: Number of Participants with a Molecular response (MR) [ Time Frame: Baseline and up to 3 years ]
  • Parts 2, 2m and 3: Number of Participants who had Best Categorical Shift in BCR-ABL1 Transcript Levels From Baseline [ Time Frame: Baseline and up to 3 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@merck.com

Locations

University of Alabama Medicine (UAB Medicine)

Recruiting

Birmingham, Alabama, United States, 35233

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80303

Florida Cancer Affiliates - Ocala

Recruiting

Ocala, Florida, United States, 34474

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

Atrium Health Levine Cancer Institute

Recruiting

Winston-Salem, North Carolina, United States, 27103

Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Thomas Jefferson University - Center City (Philadelphia)

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Tristar BMT

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • allosteric inhibitor of BCR-ABL1
  • CML
  • TERN-701
  • chronic myeloid leukemia
  • T315I
  • T315I mutant
  • CARDINAL
  • HS-10382

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.