NCT07602842RecruitingPhase 1/2
A Study of IDP-001 in Advanced or Metastatic Solid Tumors
A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 8 May 2026
- Start date
- 8 Jul 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- InduPro, Inc.
- NCT number
- NCT07602842
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 132
- From 8 Jul 2026 to the primary completion date, Jun 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major immunologic reaction to prior immunoglobulin G-containing agent
- Participation in a concurrent clinical study in the treatment period
- Unresolved toxicities from previous anticancer therapy
- Has had a seizure prior to Screening
- Prior solid organ transplant or allogeneic stem cell transplant
- History or interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids
- Stroke or transient ischemic attack prior to Screening
Other illness
- 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
- Active autoimmune disease
- History or active skin disease requiring frequent treatment
- Clinically significant ascites or liver disease
- Uncontrolled diabetes or diabetic neuropathy
- Active bleeding disorders
- Known hypersensitivity to IDP-001 or any of its ingredients
- History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
- 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.
Other
- Requires home oxygen
- Pregnant or lactating or planning to become pregnant
- Current endocrinopathy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| START Dallas Forth Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Community Cancer Center North Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| START New York Long Island Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| START - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.