ADVANCED SOLID TUMORS: PHASE 1: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

Title
Sumitomo BBI-DSP7888-102CI
Study Title

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

Site Link
Malignancy
Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st or later
Investigational Agent
DSP-7888
Drug Class
peptide vaccine stimulating cytotoxic T-cells expressing WT1
PI
Dan Vaena, MD
Sponsor
Sumitomo Dainippon Pharma Oncology Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
  • Must not be eligible for curative resection
  • Must be positive for at least 1 of the following human leukocyte antigens:
    • HLA-A*02:01
    • HLA-A*02:06
    • HLA-A*24:02
    • HLA-A*03:01
    • HLA-B*15:01
  • ECOG PS 0-1
  • No known CNS mets
  • No known HIV/HBV/HCV
Objective
  • Primary
    • DLTs, RP2D
    • Prelim antitumor activity
  • Secondary
    • ORR
    • DCR
    • DOR
    • PFS
    • OS
    • immune related ORR, DCR, PFS, OS
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X