Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-28 @ 9:33 PM
Study NCT ID:
NCT05653661
Status:
WITHDRAWN
Last Update Posted:
2025-01-07
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase I Study of Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) in Patients with Advanced Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor business considerations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety, side effects, and best dose of a new drug called nab-paclitaxel/STI-3031 complex (AP160-complex) in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other distant parts of the body (metastatic). AP160-complex is a combination of the chemotherapy drug nab-paclitaxel, and the immunotherapy drug STI-3031. Nab-paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. AP160-complex may work better than standard therapies in treating advanced or metastatic solid tumors.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for nab-paclitaxel/danburstotug complex AP160 (AP160).
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of AP160 when administered as an intravenous (IV) infusion.
II. To determine the best response with AP160.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess the evidence of immune response. II. To characterize the pharmacokinetics of paclitaxel administered in the context of AP160-complex.
III. To assess the tumor concentrations of paclitaxel 24 hours (h) following AP160-complex infusion and correlation with plasma levels.
IV. To assess the antitumor activity of the recommended phase II dose of AP160 in patients with metastatic solid tumors.
OUTLINE: This is a phase I, dose-escalation study followed by a dose-expansion study.
Patients receive AP160-complex IV on study. Patients in the dose-escalation cohort undergo computed tomography/magnetic resonance imaging (MRI) scans, tissue biopsies, and collection of blood samples throughout the trial. Patients in the dose-expansion cohort undergo MRI scan during screening, collection of blood samples during screening and on study, and tissue biopsies throughout the trial.
I. To determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) for nab-paclitaxel/danburstotug complex AP160 (AP160).
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of AP160 when administered as an intravenous (IV) infusion.
II. To determine the best response with AP160.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess the evidence of immune response. II. To characterize the pharmacokinetics of paclitaxel administered in the context of AP160-complex.
III. To assess the tumor concentrations of paclitaxel 24 hours (h) following AP160-complex infusion and correlation with plasma levels.
IV. To assess the antitumor activity of the recommended phase II dose of AP160 in patients with metastatic solid tumors.
OUTLINE: This is a phase I, dose-escalation study followed by a dose-expansion study.
Patients receive AP160-complex IV on study. Patients in the dose-escalation cohort undergo computed tomography/magnetic resonance imaging (MRI) scans, tissue biopsies, and collection of blood samples throughout the trial. Patients in the dose-expansion cohort undergo MRI scan during screening, collection of blood samples during screening and on study, and tissue biopsies throughout the trial.
Study Oversight
Has Oversight DMC:
True
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?: