Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563375
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1 Dose Escalation and Dose Expansion Trial of NP-101 in Patients With Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the safety and preliminary efficacy of NP-101 in patients with solid tumors
Detailed Description:
Primary Objective
To determine the safety and tolerability of NP-101 in patients with solid tumors
Secondary Objective
To determine the preliminary antitumor activity of NP-101 Although the clinical benefit of NP-101 has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
Exploratory Objectives
To evaluate immune-related markers of response and resistance to NP-101 To bank blood samples for future pharmacokinetic PK analyses of NP-101
To determine the safety and tolerability of NP-101 in patients with solid tumors
Secondary Objective
To determine the preliminary antitumor activity of NP-101 Although the clinical benefit of NP-101 has not yet been established the intent of offering this treatment is to provide a possible therapeutic benefit and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability
Exploratory Objectives
To evaluate immune-related markers of response and resistance to NP-101 To bank blood samples for future pharmacokinetic PK analyses of NP-101
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None