Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-676 · 1 trial · 1 indication
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites in each resected patient sample by IHC and ISH. An aggregate analysis of this quantification may be done across patient samples in each substudy to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to, biomarkers for cell death (e.g., cleaved caspase 3), T-cells (e.g., Cluster of Differentiation 3 (CD3), Cluster of Differentiation 8/Granzyme B, Cluster of Differentiation), natural killer (NK)/myeloid cells (e.g., Cluster of Differentiation 56/Granzyme B, Cluster of Differentiation 86, Cluster of Differentiation 68, Cluster of Differentiation 163), and proinflammatory cytokines (e.g., interferon gamma, tumor necrosis factor alpha, interferon gamma-induced protein 10).
| Arm | Type | Description |
|---|---|---|
| TAK-676, Carboplatin, 5-FU, & Paclitaxel | EXPERIMENTAL | Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected at least four hours to up to four days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of TAK-676, carboplatin, 5-fluorouracil (5- FU), or paclitaxel as single agents or in combination. Each microdose is simultaneously injected in a columnar fashion through each of 8, 5, or 3 needles (in a device configuration determined by tumor dimensions) into a single solid tumor or effaced metastatic lymph node. |
| Name | Type | Description |
|---|---|---|
| TAK-676 | DRUG | Intratumoral microdose injection by the CIVO device. |
| Carboplatin | DRUG | Intratumoral microdose injection by the CIVO device. |
| 5-FU | DRUG | Intratumoral microdose injection by the CIVO device. |
| Paclitaxel | DRUG | Intratumoral microdose injection by the CIVO device. |
| TAK-676 + Carboplatin | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| Carboplatin + Paclitaxel | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| Carboplatin + 5-FU | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| TAK-676 + Carboplatin + 5-FU | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| TAK-676 + Carboplatin + Paclitaxel | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
Inclusion Criteria: 1. Ability and willingness to comply with the study's visit and assessment schedule. 2. Male or female ≥ 18 years of age at Visit 1 (Screening). 3. Pathologic diagnosis of Head and Neck Squamous Cell Carcinoma (HNSCC). 4. Ability and willingness to provide written informed conse...
TAK-676 is an investigational small molecule being studied for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.
TAK-676 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical research on this investigational oncology drug for the treatment of Head and Neck Squamous Cell Carcinoma.
TAK-676 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The drug is being studied for the treatment of Head and Neck Squamous Cell Carcinoma, and its clinical trial status is completed.
TAK-676 has one completed clinical trial, identified as NCT06062602, titled "PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC." This early Phase 1 study enrolled 15 participants in the United States and was uncontrolled, meaning there was no comparator arm.
TAK-676 is not the same as PBI-MST-01. PBI-MST-01 is a separate clinical trial, identified as NCT04541108, and TAK-676 was studied as a substudy within that trial. The substudy, NCT06062602, specifically evaluated intratumoral microdosing of TAK-676 in patients with Head and Neck Squamous Cell Carcinoma.