This clinical study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of IDP-001 in participants with advanced or metastatic squamous and non-squamous NSCLC and other squamous cell solid tumors (for example, head and neck, esophageal, cervical, cutaneous).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
IV infusion
Hackensack Meridian - John Theurer Cancer Center
Edison, New Jersey, United States
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
Time frame: 3 weeks
Phase 1 Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Time frame: Approximately 6 months
Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Area Under the Concentration Time Curve (AUC) of IDP-001
Time frame: Approximately 6 months
Maximum Observed Plasma Concentration (Cmax) of IDP-001
Time frame: Approximately 6 months
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Time frame: Approximately 6 months
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Dose Reduction, Dose Interruption, and Dose Discontinuation
Time frame: Approximately 6 months
Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator
Time frame: Approximately 6 months
Phase 1 Part 2: Overall Survival (OS)
Time frame: Approximately 18 months
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