Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04065555 | Intratumoral Microdosing of TAK-981 in Head and Neck Cancer | EARLY_PHASE1 | COMPLETED | 12 | — | — | Oct 7, 2020 | Jul 20, 2022 | Jul 29, 2022 | 6 | United States |
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites of each resected patient sample by IHC and ISH. An aggregate analysis of this quantification may be done across patient samples to evaluate trends in tumor response. List of biomarkers evaluated may include biomarkers for cell death (e.g. cleaved caspase 3), T-cells (e.g. CD3, CD8/Granzyme B), and natural killer (NK) or myeloid cells (e.g. CD56/Granzyme B, CD86, CD68).
| Arm | Type | Description |
|---|---|---|
| CIVO Microdose Injection of TAK-981, Cetuximab, and Avelumab | EXPERIMENTAL | Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected one day (Cohort 1) or three days (Cohort 2) 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-981, cetuximab, avelumab, TAK-981 combined with cetuximab, or TAK-981 combined with avelumab. 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. Approximately six patients will be assigned to each time point cohort. Cohort assignment is not sequential and will be selected by the Investigator based on clinic logistics and patient scheduling. Should one cohort fill in advance of the other, sites will be directed by Presage to enroll patients into the second cohort only. |
| Name | Type | Description |
|---|---|---|
| TAK-981 | DRUG | Intratumoral microdose injection by the CIVO device. |
| Cetuximab | BIOLOGICAL | Intratumoral microdose injection by the CIVO device. |
| Avelumab | BIOLOGICAL | Intratumoral microdose injection by the CIVO device. |
| TAK-981 + Cetuximab | COMBINATION_PRODUCT | Intratumoral microdose injection by the CIVO device. |
| TAK-981 + Avelumab | 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 primary cancers of the head and neck. 4. Ability and willingness to provide written informed consent. Volun...