Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05797805
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Iterion Therapeutics
Organization:
Study Overview
Official Title:
A Phase 1/2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-07
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:
This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation, and dose optimization, study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib) followed by a combination dose expansion.
Detailed Description:
This study will be conducted in patients with advanced hepatocellular carcinoma (HCC) who have progressed after at least one prior line of systemic therapy.
Tegavivint will be administered as a single agent first in a dose escalation and optimization design. Single agent dose escalation will follow a standard 3+3 design to determine the tegavivint maximum tolerated dose (MTD). Upon completion of the dose escalation design and review of all available safety, efficacy, PK and PD data the Safety Review Committee (SRC) will recommend two dose levels for dose selection optimization. The dose selection optimization will expand the two dose levels to approximately 20 patients randomized (1:1) per dose level (approximately 40 patients total) before declaring the recommended phase 2 dose (RP2D).
If sufficient clinical benefit is observed, the combination of tegavivint plus cabozantinib and tegavivint plus lenvatinib will be explored in the second part of the study. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib). The starting dose level of tegavivint will be decided by the SRC and will start at either one dose level below the MTD or at a lower dose as defined by the SRC. The dose escalations will follow a standard 3+3 design, and the dose escalation increments for tegavivint will follow the monotherapy dose escalation schedule to determine the combinations MTDs. Upon completion of the combination dose escalations, approximately 12 additional patients will be enrolled in each combination arm at the tegavivint combination MTDs.
Tegavivint will be administered as a single agent first in a dose escalation and optimization design. Single agent dose escalation will follow a standard 3+3 design to determine the tegavivint maximum tolerated dose (MTD). Upon completion of the dose escalation design and review of all available safety, efficacy, PK and PD data the Safety Review Committee (SRC) will recommend two dose levels for dose selection optimization. The dose selection optimization will expand the two dose levels to approximately 20 patients randomized (1:1) per dose level (approximately 40 patients total) before declaring the recommended phase 2 dose (RP2D).
If sufficient clinical benefit is observed, the combination of tegavivint plus cabozantinib and tegavivint plus lenvatinib will be explored in the second part of the study. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib). The starting dose level of tegavivint will be decided by the SRC and will start at either one dose level below the MTD or at a lower dose as defined by the SRC. The dose escalations will follow a standard 3+3 design, and the dose escalation increments for tegavivint will follow the monotherapy dose escalation schedule to determine the combinations MTDs. Upon completion of the combination dose escalations, approximately 12 additional patients will be enrolled in each combination arm at the tegavivint combination MTDs.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: