At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TERN-701 (drug)
- How long the study runs
- Study runs about 74 months (dates as stated)
- About the drug or intervention
- TERN-701 — drug: TERN-701 orally QD
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a new medicine called TERN-701 in adults with chronic myeloid leukaemia (CML), a type of blood cancer, in the chronic (stable) stage. It is looking at how safe the medicine is, how well people cope with it, how it moves through the body, and whether it works. It is a Phase 1/2 study called CARDINAL, run by Terns, Inc., a subsidiary of Merck & Co., Inc.
Who can take part
- Adults aged 18 or over
- Have a confirmed diagnosis of CML that tests positive for BCR-ABL1 and is in the chronic (stable) stage
- Have already had at least one previous TKI (tyrosine kinase inhibitor, a targeted cancer medicine) treatment that stopped working well enough or was not tolerated
- Previous treatment with asciminib is allowed
- Well enough to take part, with an ECOG performance status score of 0 to 2 (a measure of how well you can carry out daily activities)
- Healthy enough organ function, based on local laboratory tests
Who may not be able to
- Having had cancer treatment (including previous TKIs, interferon-alfa, therapeutic antibodies or chemotherapy) or other experimental therapy within 7 days before the first dose of TERN-701
- Still having significant side effects from earlier cancer treatment (worse than Grade 2 or above your starting level)
What taking part involves
- • Taking TERN-701 as part of a Phase 1/2 study. Not stated — ask the trial team about how the medicine is given, the dose and how long treatment lasts.
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 180
- Started
- 2024-03-26
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for chronic myeloid leukemia, chronic phase
- • Phase1/Phase2 - 180 participants
- • The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic myeloid leukemia, chronic phase
Where?
- • London - Imperial College Healthcare NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML). The study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily. Part 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations. In both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter. Approximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort). All participants will receive active trial intervention. Four dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ asciminib is allowed
What the study is looking for
- ✓Male or female participants ≥ 18 years of age at the time of signing the agreement to take part
- ✓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...
- ✓Prior treatment with asciminib is allowed
Who cannot take part
- ✗Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, drug treatment) or...
- ✗Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to...
See the full criteria
Where Is This Study? (1 UK site)
Imperial College Healthcare NHS Trust
London W12 0HS, United Kingdom
How to Get in Touch
Study Director
Sponsor contactCONTACT