Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420349
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-08
Brief Title:
NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase 1b Study of the Novel GCN2 Kinase Activator NXP800 in Patients With Advanced Cholangiocarcionoma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety best dose and effectiveness of NXP800 in treating patients with cholangiocarcinoma that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced or that has spread from where it first started primary site to other places in the body metastatic NXP800 inhibits a pathway called the heat shock factor 1 HSF1 pathway The inhibition of this pathway inhibits proliferation migration survival and metastasis in susceptible tumor cells Overexpressed amplified andor overactivated in many cancer cells HSF1 activates a set of genes that play a key role in tumor initiation progression and metastasis Inhibiting this pathway may in turn inhibit tumor initiation progression andor metastasis Giving NXP800 may be safe tolerable andor effective in treating patients with advanced or metastatic cholangiocarcinoma
Detailed Description:
PRIMARY OBJECTIVE
I To determine the maximum tolerated dose MTDrecommended phase 2 dose for heat shock factor 1 pathway inhibitor NXP800 NXP800
SECONDARY OBJECTIVES
I To determine the toxicity profile of NXP800 II To determine the best response for NXP800 using Response Evaluation Criteria in Solid Tumors RECIST version v11
III To estimate the overall survival OS for NXP800 IV To estimate the progression-free survival PFS for NXP800
EXPLORATORY OBJECTIVES
I To evaluate transcriptomic features associated with sensitivity resistance and pharmacodynamic effect of NXP800 using serial ribonucleic acid-sequencing RNA-Seq
II To assess tumor evolution with NXP800 using serial whole genome-sequencing Seq
III To assess tumor evolution with NXP800 using serial circulating tumor deoxyribonucleic acid DNA ct-DNA
IV To estimate tumor marker response using serial CA19-9carcinoembryonic antigen CEA
OUTLINE This is a dose de-escalation study of NXP800 followed by a dose-expansion study
Patients receive NXP800 orally PO once daily QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PET at baseline and on study Patients may optionally undergo ultrasound-guided liver biopsy andor collection of blood samples on study and during follow up
After completion of study treatment patients are followed up every 6 months until progressive disease or death for up to 3 years
I To determine the maximum tolerated dose MTDrecommended phase 2 dose for heat shock factor 1 pathway inhibitor NXP800 NXP800
SECONDARY OBJECTIVES
I To determine the toxicity profile of NXP800 II To determine the best response for NXP800 using Response Evaluation Criteria in Solid Tumors RECIST version v11
III To estimate the overall survival OS for NXP800 IV To estimate the progression-free survival PFS for NXP800
EXPLORATORY OBJECTIVES
I To evaluate transcriptomic features associated with sensitivity resistance and pharmacodynamic effect of NXP800 using serial ribonucleic acid-sequencing RNA-Seq
II To assess tumor evolution with NXP800 using serial whole genome-sequencing Seq
III To assess tumor evolution with NXP800 using serial circulating tumor deoxyribonucleic acid DNA ct-DNA
IV To estimate tumor marker response using serial CA19-9carcinoembryonic antigen CEA
OUTLINE This is a dose de-escalation study of NXP800 followed by a dose-expansion study
Patients receive NXP800 orally PO once daily QD on days 1-28 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT magnetic resonance imaging MRI andor positron emission tomography PET at baseline and on study Patients may optionally undergo ultrasound-guided liver biopsy andor collection of blood samples on study and during follow up
After completion of study treatment patients are followed up every 6 months until progressive disease or death for up to 3 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03613 | REGISTRY | None | None |
| MC230406 | OTHER | None | None |
| 23-012778 | OTHER | Mayo Clinic Institutional Review Board | None |