A Phase 1/1b First-In-Human Multi-Part Open-Label Study to Investigate the Safety Tolerability Pharmacokinetics Biological and Clinical Activity of DF6215 in Patients with Advanced (Unresectable Recurrent or Metastatic) Solid Tumors

Brief description of study

This is a study is testing a new drug called DF6215 on patients with tough-to-treat (unresectable, recurrent or metastatic) solid tumors. The goal is to see if the treatment has few side effects and if it is effective in treating the tumors. The study is being done in two parts. First, the study team is testing different doses to find out how much patients can tolerate of DF6215 without getting too sick or without dealing with side effects. Then, the study team will give the best dose from the first part to more patients to see if it helps them with their tumors. The drug will be given through a vein every other week for a month. The study team will keep a close eye on how every patient is doing to make sure the drug is safe and effective.


Clinical Study Identifier: s23-01450
ClinicalTrials.gov Identifier: NCT06108479
Principal Investigator: Maya Dimitrova.
Other Investigators: Joshua K Sabari, Samantha VanMaanen, Eneil De La Pena, Salman Rafi Punekar, Elaine Shum, Jessica Wang, Kristen Spencer, Douglas K Marks, Scot Niglio, Keriann M Scavone, Kathleen M Madden, Nancy Chan, Kirby Rodriguez, Nina Beri, Janice Mehnert, David R. Wise.


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