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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests MK-4208 (Tern-701) for chronic myeloid leukemia (CML), a blood cancer, in people who have already tried treatment. Researchers want to find the highest dose people can tolerate and learn if it may help treat CML.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can do daily self-care and are up and about for at least half of waking hours (ECOG score 0–2).
  • Have CML confirmed by cell testing, with the BCR-ABL1 gene change, in its chronic (slow-growing) phase.
  • Have tried at least one tyrosine kinase inhibitor (TKI), a targeted cancer drug, that did not work well enough or caused side effects you could not tolerate.
  • Past treatment with asciminib is allowed.
  • Have organs that work well enough, based on local lab tests.

Who can't join

  • Received cancer treatment that acts throughout the body or another experimental treatment within 7 days before the first study dose.
  • Still have significant side effects from past cancer treatment that have not improved to moderate or milder levels (grade 2 or lower), or to their level before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (18)

AL

AZ

CA

CO

FL

GA

NC

NY

OR

PA

TN

TX

UT

WA