ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.
Active, not recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| ADU-S100 | MIW815 | ADU-S100 and pembrolizumab |
| Name | Type | Description | Interventions |
|---|---|---|---|
| ADU-S100 and pembrolizumab | Experimental | All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100. |
|
Inclusion Criteria:
- Histological or cytological confirmation of recurrent or metastatic HNSCC
- Measurable disease as defined by RECIST v1.1
- PD-L1 positive
Exclusion Criteria:
- Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell
carcinoma of unknown primary histology; or salivary gland or non-squamous histologies
(e.g. mucosal melanoma)
- Disease amenable to local therapy with curative intent (surgery or radiation therapy
with or without chemotherapy)
- Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small
molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or
metastatic HNSCC
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Evaluation of clinical activity by the objective response rate (ORR; complete response [CR] and partial response [PR]) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Time Frame: | 25 months |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Chinook Therapeutics, Inc. |
March 10, 2021
