Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2026-01-09 @ 1:27 PM
Study NCT ID:
NCT06062602
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2023-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC
Sponsor:
Presage Biosciences
Organization:
Study Overview
Official Title:
TAK-676 Alone and in Combination(s) With Carboplatin, 5-Fluorouracil, and Paclitaxel in Patients With Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-10
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 is a multi-center, open-label Phase 0 substudy designed to study the localized pharmacodynamics (PD) of TAK-676 alone or in combination with Carboplatin, 5-FU, or Paclitaxel within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients diagnosed with Head and Neck Squamous Cell Carcinoma presenting with a surface accessible solid tumor for which there is a scheduled surgical intervention. This substudy is a cohort of the PBI-MST-01 Master Protocol.
Detailed Description:
CIVO is a research tool composed of a hand-held single-use sterile injector coupled with fluorescent tracking microspheres called CIVO GLO that mark the sites of drug microdose injection, enabling rapid assessment of multiple oncology drugs or drug combinations simultaneously within a patient's tumor. Tumor responses to cancer treatments are highly context-specific and often involve complex interactions between the anti-cancer therapy, genetically diverse tumor cells, and a heterogeneous TME. This complexity is rarely modeled accurately in preclinical translational models of cancer.
In this Phase 0 intratumoral microdosing substudy in human patients with Head and Neck Squamous Cell Carcinoma (who will be undergoing previously planned tumor and/or regional node dissection), we will evaluate the ability of TAK-676 to activate innate immune effector cells within the local tumor microenvironment. Additionally, this study will examine the effect of TAK-676 in combination with Carboplatin, or Paclitaxel, or in combination with 2 agents Carboplatin and 5-FU, or Carboplatin and Paclitaxel to study whether TAK-676 enhances the localized immune responses compared to both immunotherapy combinations or Carboplatin alone. All investigational drug combinations will be delivered intratumorally in subtherapeutic microdose quantities via the CIVO platform.
The CIVO Microdose Injection Device (MID) penetrates solid tumors and delivers subtherapeutic microdoses of up to eight anti-cancer agents, or combinations of anti-cancer agents, co-injected with CIVO GLO into discrete regions of the tumor. At the time of the planned surgical intervention (4 hours up to four days after the CIVO microdose injection), the injected tumor tissue is then excised and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column. Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for biomarker analysis. Because the platform delivers microdose amounts of each test agent, or combination, directly into the patient's tumor tissue, mechanistic hypotheses can be tested early in the drug development process, consistent with the goals of the 2006 FDA Exploratory Investigational New Drug (IND) Guidance for Industry.
In this Phase 0 intratumoral microdosing substudy in human patients with Head and Neck Squamous Cell Carcinoma (who will be undergoing previously planned tumor and/or regional node dissection), we will evaluate the ability of TAK-676 to activate innate immune effector cells within the local tumor microenvironment. Additionally, this study will examine the effect of TAK-676 in combination with Carboplatin, or Paclitaxel, or in combination with 2 agents Carboplatin and 5-FU, or Carboplatin and Paclitaxel to study whether TAK-676 enhances the localized immune responses compared to both immunotherapy combinations or Carboplatin alone. All investigational drug combinations will be delivered intratumorally in subtherapeutic microdose quantities via the CIVO platform.
The CIVO Microdose Injection Device (MID) penetrates solid tumors and delivers subtherapeutic microdoses of up to eight anti-cancer agents, or combinations of anti-cancer agents, co-injected with CIVO GLO into discrete regions of the tumor. At the time of the planned surgical intervention (4 hours up to four days after the CIVO microdose injection), the injected tumor tissue is then excised and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column. Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for biomarker analysis. Because the platform delivers microdose amounts of each test agent, or combination, directly into the patient's tumor tissue, mechanistic hypotheses can be tested early in the drug development process, consistent with the goals of the 2006 FDA Exploratory Investigational New Drug (IND) Guidance for Industry.
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PBI-MST-01 | OTHER | Presage Biosciences | View |