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BCR-ABL1 Inhibitor

Part 2 - Dose 1 for Chronic Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Terns, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase with or without T315l mutation

Male or female participants ≥ 18 years of age at the time of signing the informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will evaluate the safety and efficacy of a novel drug (TERN-701) used to treat chronic myeloid leukemia (CML) in up to 80 participants.

Who is the study for?

This trial is for adults over 18 with chronic myeloid leukemia who've had issues with previous treatments like intolerance or inadequate response. They should be relatively active (able to walk and do light activities), have their major organs working well, and not be in the advanced stages of leukemia.Check my eligibility

What is being tested?

TERN-701, a new drug aimed at treating chronic myeloid leukemia, is being tested. The study has two parts: first, finding the right dose by increasing it gradually; second, giving more people this chosen dose to see how effective and safe it is when taken daily in cycles of 28 days.See study design

What are the potential side effects?

Specific side effects aren't listed here but generally could include reactions related to organ function changes due to the medication's action on cancer cells. Regular check-ups are scheduled to monitor these potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia is confirmed to be BCR-ABL1 positive in the chronic phase.

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I am 18 years or older and have given my consent.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 - Adverse Events

Part 1 - Incidence of Dose Limiting Toxicities during the first cycle of treatment

Part 1 - Serious Adverse Events

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2 - Dose 2Experimental Treatment1 Intervention

Dose 2 will be selected from Part 1 based on the totality of safety, PK, PD and efficacy data from Part 1 will be selected. TERN-701 is planned to be administered once daily.

Group II: Part 2 - Dose 1Experimental Treatment1 Intervention

Dose 1 will be selected from Part 1 based on the totality of safety, PK, PD and efficacy data from Part 1 will be selected. TERN-701 is planned to be administered once daily.

Group III: Part 1- Dose Level 4 of TERN-701Experimental Treatment1 Intervention

Dose Level 4 of TERN-701 dosed once daily.

Group IV: Part 1- Dose Level 3 of TERN-701Experimental Treatment1 Intervention

Dose Level 3 of TERN-701 dosed once daily.

Group V: Part 1- Dose Level 2 of TERN-701Experimental Treatment1 Intervention

Dose Level 2 of TERN-701 dosed once daily.

Group VI: Part 1- Dose Level 1 of TERN-701Experimental Treatment1 Intervention

Dose Level 1 of TERN-701 dosed once daily.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Terns, Inc.Lead Sponsor

3 Previous Clinical Trials

315 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for prospective participants to join this research endeavor?

"Clinicaltrials.gov confirms that this research project has concluded its patient recruitment process, with the initial posting dating back to December 13th 2023 and the most recent update being November 30th of the same year. Nevertheless, there are still 1476 other studies actively searching for patients at present."

Answered by AI

Has the Food & Drug Administration given its consent to Part 1-Dose Level 2 of TERN-701?

"Due to the limited existing data on TERN-701 Part 1 - Dose Level 2, our team assigned it a score of 1 for safety. This is typical in Phase 1 trials where efficacy and safety have yet to be established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163430.