Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-08
Brief Title:
CARDINAL- A Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Sponsor:
Terns Inc
Organization:
Terns Inc
Study Overview
Official Title:
A Phase 1 Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of TERN-701 a novel 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 at least 2 recommended dose levels for expansion selected from Part 1
In both Part 1 and Part 2 participants will receive continuous 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 1C1D1 C1D2 C1D8 C1D15 and C1D16 followed by Day 1 of Cycles 2 through 7 and Day 1 of every 3 cycles thereafter
Approximately 60 to 80 participants could be enrolled in this trial including approximately 24 to 36 participants in Part 1 dose escalation including optional backfill cohorts and approximately 40 participants in Part 2 randomized dose expansion
All participants will receive active trial intervention
Up to 4 dose-level cohorts may be evaluated in Part 1 at least 2 dose levels may be evaluated in Part 2
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 at least 2 recommended dose levels for expansion selected from Part 1
In both Part 1 and Part 2 participants will receive continuous 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 1C1D1 C1D2 C1D8 C1D15 and C1D16 followed by Day 1 of Cycles 2 through 7 and Day 1 of every 3 cycles thereafter
Approximately 60 to 80 participants could be enrolled in this trial including approximately 24 to 36 participants in Part 1 dose escalation including optional backfill cohorts and approximately 40 participants in Part 2 randomized dose expansion
All participants will receive active trial intervention
Up to 4 dose-level cohorts may be evaluated in Part 1 at least 2 dose levels may be evaluated in Part 2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None