A Clinical Study of MK-4208/TERN-701 in Participants With Chronic Myeloid Leukemia (CML) (MK-4208-003/Tern701-1012/CARDINAL)

a study on Leukemia Chronic Myeloid Leukemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Richard Van Etten

Description

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.

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

Keywords

Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Chronic Myeloid Leukemia, Chronic Phase, Chronic Myeloid Leukemia, allosteric inhibitor of BCR-ABL1, CML, TERN-701, T315I, T315I mutant, CARDINAL, HS-10382, Leukemia, Myeloid, Chronic-Phase, MK-4208 320 mg QD, MK-4208 400 mg QD, MK-4208 500 mg QD

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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)

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • Banner MD Anderson Cancer Center accepting new patients
    Gilbert Arizona 85234 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
ID
NCT06163430
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 330 study participants
Last Updated
Contact us about this trial