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NCT07602842PHASE1, PHASE2Recruiting

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

InduPro, Inc.

Start Date

6/1/2026

Completion Date

12/1/2028

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

IDP-001

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Conditions

Advanced Solid TumorMetastatic Solid TumorHead and Neck Squamous Cell CarcinomaCutaneous Squamous Cell CarcinomaSquamous Cell Carcinoma of the CervixNon Squamous Non Small Cell Lung CancerSquamous Cell Carcinoma of the EsophagusSquamous Cell Carcinoma of the AnusSquamous Cell Carcinoma

Locations

START Los Angeles

Los Angeles, California 90025

United States

Hackensack Meridian - John Theurer Cancer Center

Edison, New Jersey 08837

United States

START New York Long Island

Lake Success, New York 11042

United States

START Dallas Forth Worth

Fort Worth, Texas 76104

United States