West Cancer Center

ADVANCED SOLID TUMORS: 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

NCT03311334

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

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Phase

Phase 1

Status

Closed to Accrual

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

Assessment Frequency 2

Assessment Frequency Link

Path

Carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized