Clinical trial for Advanced Solid Tumor
Official title A Study of IDP-001 in Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07602842
What this study is testing
What is IDP-001?
IDP-001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Active significant neurologic disorders
- Requires home oxygen
- Active autoimmune disease
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Sarasota, Florida, United States
- Indianapolis, Indiana, United States
- Buffalo, New York, United States
- Lake Success, New York, United States
- Fort Worth, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Sarasota, Florida, United States; Indianapolis, Indiana, United States; Buffalo, New York, United States; Lake Success, New York, United States; Fort Worth, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.