A Study of IDP-001 in Advanced or Metastatic 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).
Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- InduPro, Inc.
- Interventions being studied
- Drug: IDP-001
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- START Los AngelesLos Angeles, California
- Florida Cancer SpecialistsSarasota, Florida
- Community Cancer Center NorthIndianapolis, Indiana
- Hackensack Meridian - John Theurer Cancer CenterEdison, New Jersey
- 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: Aug 27, 2026. Always confirm current availability with the study team.