CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia

Launched by TERNS, INC. · Nov 30, 2023

Keywords

ClinConnect Summary

The CARDINAL clinical trial is studying a new medication called TERN-701 to see how safe and effective it is for people with chronic myeloid leukemia (CML) who have already received treatment. The trial has two parts: the first part will gradually increase the dose of TERN-701 to find the best amount to use, while the second part will compare different doses to see which one works best. Participants will take the medication once a day for 28 days at a time and will have regular visits to the trial center to monitor their progress.

To be eligible for this trial, participants must be adults aged 18 or older with a confirmed diagnosis of BCR-ABL1 positive CML that is in a chronic phase. They should have previously been treated with targeted therapies and either not responded well, experienced side effects, or had treatment failures. Participants will receive the active study medication and be closely monitored throughout the trial. This is an important opportunity for those looking for new treatment options for their CML, as the study aims to find effective ways to manage this condition.

Gender

ALL

Eligibility 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 active site targeting TKIs and have treatment failure, suboptimal response, or treatment intolerance
• • Prior treatment with asciminib may be 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)