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Recruiting Phase 1/2

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

NCT07602842 · tracked via the Priya Life Science USA tracker
Sponsor
InduPro, Inc
Phase
Phase 1/2
Started
2026-07-08
Last updated
2026-09-03

Condition(s) studied

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

Investigational drug(s) / intervention(s)

IDP-001

IDP-001: IV infusion

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (6)

FacilityCityRegionStatus
START Los Angeles Los Angeles California Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Community Cancer Center North Indianapolis Indiana Recruiting
Roswell Park Cancer Institute Buffalo New York Recruiting
START New York Long Island Lake Success New York Recruiting
START Dallas Forth Worth Fort Worth Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07602842 on ClinicalTrials.gov ↗ ← All trials in the USA