TuHURA Biosciences, Inc.
This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.
Inclusion Criteria: 1. At least 18 years of age. 2. Life expectancy equal to or greater than six months. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2. 4. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma 1. Must have at least one injectable lesion equal to or greater than 3 mm. 2. Must have measurable disease as defined by RECIST v1.1. 5. Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizum…
Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
Route of Administration: • Intralesional
Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion