A Study of IDP-001 in Advanced or Metastatic Solid Tumors

A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors

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 Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Esophagus; Cutaneous Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Anus; Squamous Cell Carcinoma of the Cervix; Non Squamous Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: IDP-001

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: InduPro Inc.; Phone Number: 617-798-1770; Email: clinicaltrials@induprotx.com

Study Locations

• United States
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Hackensack Meridian - John Theurer Cancer Center
      • Contact: Miguel Gonzalez Velez, M.D.; Phone Number: 480-232-2015; Email: clinicaltrials@induprotx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Participant willing to provide tumor biopsies
• Adequate organ function
• Agree to contraception requirements as outlined in the protocol
• Life expectancy greater than 12 weeks

Exclusion Criteria:

• 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
• Requires home oxygen
• Active autoimmune disease
• History or active skin disease requiring frequent treatment
• History of major immunologic reaction to prior immunoglobulin G-containing agent
• Clinically significant ascites or liver disease
• Uncontrolled diabetes or diabetic neuropathy
• Active bleeding disorders
• Participation in a concurrent clinical study in the treatment period
• Pregnant or lactating or planning to become pregnant
• Known hypersensitivity to IDP-001 or any of its ingredients
• Unresolved toxicities from previous anticancer therapy
• Has had a seizure prior to Screening
• Prior solid organ transplant or allogeneic stem cell transplant
• Current endocrinopathy
• History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
• History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids
• Stroke or transient ischemic attack prior to Screening
• Participant has any other condition or illness that, in the opinion of the Investigator, may compromise participant safety, compliance, or interfere with the conduct and evaluation of the current study.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Part 1 Dose Escalation; Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.	Drug: IDP-001; IV infusion
Experimental: Phase 1 Part 2 Indication Selection; Participants with a single tumor indication will receive IDP-001 as IV infusion	Drug: IDP-001; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase 1 Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) during Cycle 1	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	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	Approximately 6 months
Phase 1 Part 2: Duration of Response (DOR) per RECIST Version 1.1 as Assessed by Investigator	Approximately 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration Time Curve (AUC) of IDP-001	Approximately 6 months
Maximum Observed Plasma Concentration (Cmax) of IDP-001	Approximately 6 months
Number of Participants with Anti-drug Antibodies (ADAs) in Blood	Approximately 6 months
Phase 1 Part 1: ORR per RECIST Version 1.1 as Assessed by Investigator	Approximately 6 months
Phase 1 Part 1: DOR per RECIST Version 1.1 as Assessed by Investigator	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	Approximately 6 months
Phase 1 Part 2: Disease Control Rate (DCR) per RECIST Version 1.1 as Assessed by Investigator	Approximately 6 months
Phase 1 Part 2: Time to Response (TTR) per RECIST Version 1.1 as Assessed by Investigator	Approximately 6 months
Phase 1 Part 2: Progression Free Survival (PFS) per RECIST Version 1.1 as Assessed by Investigator	Approximately 6 months
Phase 1 Part 2: Overall Survival (OS)	Approximately 18 months

Collaborators and Investigators

• Sponsor: InduPro, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; Squamous NSCLC
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Esophageal Neoplasms; Anus Diseases; Rectal Neoplasms; Pathological Conditions, Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Carcinoma, Squamous Cell; Neoplasm Metastasis; Anus Neoplasms
• Other Study ID Numbers: IDP-001-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No