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RecruitingPhase 1 / Phase 2NCT07602842
Official study title

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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIDP-001

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?InduPro, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
InduPro, Inc.
Interventions being studied
Drug: IDP-001
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • START Los AngelesLos Angeles, California
  • Florida Cancer SpecialistsSarasota, Florida
  • Community Cancer Center NorthIndianapolis, Indiana
  • Roswell Park Cancer InstituteBuffalo, New York
  • START New York Long IslandLake Success, New York
  • START Dallas Forth WorthFort Worth, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 3, 2026. Always confirm current availability with the study team.

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