Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

Chinook Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer

Treatments: Drug: ADU-S100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03937141

ADU-CL-20

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

ADU-S100 and pembrolizumab

Experimental group

Description:

All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.

Treatment:

Drug: ADU-S100