Title
A Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination With Nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

Description
DF9001-001 is a study of a new molecule that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors that express epidermal growth factor receptor (EGFR). A combination therapy cohort will be opened for enrollment, DF9001 + nivolumab. The second phase will include a dose expansion using the best dose selected from the first phase of the study. Multiple cohorts will be opened with eligible patients having selected solid tumors.

Objective
Primary Phase 1:
-Determine the MTD of DF9001 as a monotherapy and in combination with nivolumab in participants with advanced (unresectable, recurrent, or metastatic) solid tumors.

Primary Phase 2:
-To assess the ORR according to RECIST 1.1 per an IERC.

Secondary:
-Assess the safety and tolerability of DF9001 as a monotherapy
-Assess the safety and tolerability of DF9001 in combination with nivolumab
-Characterize the PK of DF9001.
-Characterize the PD of DF9001 as a monotherapy.
-Characterize the PD of DF9001 in combination with nivolumab
-Evaluate the immunogenicity of DF9001.
-Correlate DF9001 exposure and clinical activity and safety.
-Assess the BOR by IERC.
-Assess the DOR by IERC.
-Assess PFS for DF9001 per an IERC.

Treatment Drug: DF9001
Drug: Nivolumab

Key Eligibility For full study eligibility, see this study's ClinicalTrials.gov record.

Applicable Disease Sites
Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital