IDP-001 in advanced or metastatic solid tumors (including head and neck and skin cancers)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional study combining Phase 1 and Phase 2 to evaluate IDP-001 in adults with advanced or metastatic squamous and non-squamous solid tumors, including head and neck, cervical, esophageal, and skin cancers. The study will assess safety, tolerability, how the drug behaves in the body (pharmacokinetics), and preliminary anti-tumor activity. Participants must have measurable disease, adequate organ function, and be willing to provide tumor biopsies; key exclusions include significant cardiac or corneal disease and active infections. Locations include sites in Los Angeles, Sarasota, and Indianapolis under InduPro, Inc. as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• START Los Angeles
  Los Angeles, California, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Community Cancer Center North
  Indianapolis, Indiana, United States Recruiting
• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting
• START New York Long Island
  Lake Success, New York, United States Recruiting
• START Dallas Forth Worth
  Fort Worth, Texas, United States Recruiting

Study contacts

• Study coordinator: InduPro Inc.
• Email: clinicaltrials@induprotx.com
• Phone: 617-798-1770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.