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Evaluating TERN-701 for Chronic Myeloid Leukemia

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

Phase1; Phase2 Interventional Terns, Inc. · NCT06163430

This study is testing a new drug called TERN-701 to see if it can safely help people with chronic myeloid leukemia who have already been treated.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorTerns, Inc. Industry-sponsored
Drugs / interventionsasciminib, chemotherapy
Locations54 sites (Birmingham, Alabama and 53 other locations)
Trial IDNCT06163430 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with BCR-ABL1 positive chronic phase chronic myeloid leukemia who have experienced treatment failure or intolerance to prior therapies.

Not a fit: Patients who have recently undergone systemic antineoplastic therapy or have unresolved significant toxicity from previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with chronic myeloid leukemia who have not responded well to existing therapies.

How similar studies have performed: Other studies involving allosteric inhibitors for chronic myeloid leukemia have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Male or female participants ≥ 18 years of age at the time of signing the informed consent
* Have an ECOG performance status score of 0 to 2
* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
* Have received treatment with at least one prior 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:

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

Where this trial is running

Birmingham, Alabama and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myeloid Leukemia, Chronic PhaseChronic Myeloid Leukemiaallosteric inhibitor of BCR-ABL1CMLTERN-701chronic myeloid leukemiaT315IT315I mutant
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.