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
START Los Angeles
Los Angeles, California, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGCommunity Cancer Center North
Indianapolis, Indiana, United States
RECRUITINGRoswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGSTART New York Long Island
Lake Success, New York, United States
RECRUITINGSTART Dallas Forth Worth
Fort Worth, Texas, United States
RECRUITINGPhase 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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