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).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options
Satisfy requirements for prior treatments per tumor type as outlined in the protocol
Measurable disease per RECIST v1.1
Any clinically significant cardiac disease
Any clinically significant corneal disorder
Known, active, and uncontrolled hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV), or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
Active significant neurologic disorders
Sequential
IDP-001
DrugIV infusion
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1
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
Phase 1 Part 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator
Area Under the Concentration Time Curve (AUC) of IDP-001
Maximum Observed Plasma Concentration (Cmax) of IDP-001
Number of Participants with Anti-drug Antibodies (ADAs) in Blood
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator
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