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Tests treatment safety and results for Chronic Myeloid Leukemia, Chronic Phase
Official title A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)
ClinicalTrials.gov ID: NCT06163430
What this study is testing
What is TERN-701?
TERN-701 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic myeloid leukemia, chronic phase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days...
- Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Orange, California, United States
- Lone Tree, Colorado, United States
- Fort Myers, Florida, United States
- Ocala, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Augusta, Georgia, United States
- New York, New York, United States
- Winston-Salem, North Carolina, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
+ 29 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Orange, California, United States; Lone Tree, Colorado, United States; Fort Myers, Florida, United States; Ocala, Florida, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.