A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

Objective:

Primary Objectives:

The primary objective of Phase 1 is to:

• Assess the safety and tolerability of DF6002 as monotherapy, and to determine the maximum tolerated dose (MTD) of Subcutaneous (SC) DF6002 in patients with advanced (unresectable, recurrent, or metastatic) solid tumors in selected indications.

The primary objective of Phase 1b is to:

• Assess the safety and tolerability of SC DF6002 in combination with intravenous (IV) Nivolumab, and to determine the MTD of DF6002 in combination with Nivolumab in patients with advanced (unresectable, recurrent, or metastatic) solid tumors in selected indications.

The primary objective of Phase 2 is:

• To assess the Objective 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), for all Efficacy Expansion Cohorts testing the clinical activity of DF6002 as a monotherapy or in combination with nivolumab.

Secondary Objectives

Phase 1

• Characterize the safety of DF6002 as a monotherapy and in combination with nivolumab
• Characterize the pharmacokinetics (PK) of DF6002 and the PK profiles of DF6002 and nivolumab when given in combination
• Evaluate immunogenicity of DF6002
• Evaluate the immunogenicity of nivolumab, when given in combination with DF6002
• Assess ORR, as determined by the Investigator using RECIST 1.1.
• Assess duration of response (DOR), as determined by the Investigator using RECIST 1.1.
• Assess clinical benefit rate (CBR), as determined by the Investigator

Phase 2

• Characterize the safety of DF6002 as a monotherapy and in combination with nivolumab
• Characterize the PK of DF6002 as a monotherapy and the PK profiles of DF6002 and nivolumab when given in combination
• Assess DOR per an IERC using RECIST 1.1.
• Assess CBR per IERC using RECIST 1.1. CBR is defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) as best response.
• Evaluate the immunogenicity of DF6002 as a monotherapy and each of DF6002 and nivolumab when give in combination, and investigate potential correlation between exposure and clinical activity.
• Assess progression free survival (PFS) per an IERC using RECIST 1.1.
• Assess median overall survival (OS) time.