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

NCT07602842 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IDP-001-101
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor; Head and Neck Squamous Cell Carcinoma; Cutaneous Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Cervix; Non Squamous Non Small Cell Lung Cancer; Squamous Cell Carcinoma of the Esophagus; Squamous Cell Carcinoma of the Anus; Squamous Cell Carcinoma

Keywords

NSCLC; Squamous NSCLC

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (2)

Phase 1 Part 1 Dose Escalation

EXPERIMENTAL

Participants with advanced or metastatic solid tumors will receive IDP-001 as intravenous (IV) infusion.

Drug: IDP-001

Phase 1 Part 2 Indication Selection

EXPERIMENTAL

Participants with a single tumor indication will receive IDP-001 as IV infusion

Drug: IDP-001

Interventions

IDP-001 DRUG

IV infusion

Phase 1 Part 1 Dose Escalation; Phase 1 Part 2 Indication Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InduPro, Inc.: lead

Study Sites (1)

Hackensack Meridian - John Theurer Cancer Center

Edison, New Jersey, 08837, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Anus Neoplasms; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Anus Diseases; Rectal Diseases

Central Study Contacts

InduPro Inc.

CONTACT

617-798-1770; clinicaltrials@induprotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)