Sponsor: Dragonfly Therapeutics
Sponsor Study ID: DF9001-001
Study Title: A Phase 1/2, 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
CTO #: 103739
NCT Number: NCT04143711
Phase: I/II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Anus, Bladder, Breast, Cervix Uteri, Colon, Esophagus, Kidney, Lip, Oral Cavity and Pharynx, Liver, Lung, Melanoma, Skin, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid
Study Objectives: Determine the maximum tolerated dose (MTD) of DF9001 as a monotherapy and in combination with nivolumab in participants with advanced (unresectable, recurrent, or metastatic) solid tumors. Assess the overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per an Independent Endpoint Review Committee (IERC).