Evaluating TERN-701 for Chronic Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and efficacy of TERN-701, a selective allosteric inhibitor of BCR-ABL1, in patients with chronic phase chronic myeloid leukemia (CP-CML) who have previously been treated. The study consists of two parts: a dose escalation phase to determine the optimal dosing and a dose expansion phase to further evaluate the drug's efficacy and safety at selected doses. Participants will receive daily doses of TERN-701 over 28-day cycles, with regular visits to monitor their health and response to treatment.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Alabama Medicine (UAB Medicine)
  Birmingham, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• UC Irvine Health
  Orange, California, United States Recruiting
• Rocky Mountain Cancer Centers, LLP
  Lone Tree, Colorado, United States Recruiting
• Florida Cancer Affiliates - Ocala
  Ocala, Florida, United States Recruiting
• Georgia Cancer Center at Augusta University
  Augusta, Georgia, United States Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@merck.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Olverembatinib monotherapy for adults with newly diagnosed chronic-phase CML

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.