RightFit
RecruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests IDP-001 in people with advanced or spreading non-small cell lung cancer and certain other solid cancers. It looks at safety, side effects, how the body handles the drug, and early signs that it may fight cancer. Other study rules may apply.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do all or most daily activities, with limits only on hard physical activity.
  • A tissue test confirms a solid cancer that is advanced, has spread, or has come back and cannot be treated with surgery or other approved treatments.
  • Your past cancer treatments meet the study rules for your cancer type.
  • Your cancer can be measured using the study's rules.
  • You are willing to give tumor tissue samples.
  • Your organs work well enough for the study.
  • You agree to follow the study's birth control rules.
  • You are expected to live more than 12 weeks.

Who can't join

  • You have serious heart disease; a serious disorder of the cornea, the clear front of the eye; serious liver disease; or a serious fluid buildup in your belly.
  • You have active, uncontrolled hepatitis B, hepatitis C, or HIV, or an uncontrolled ongoing infection needing treatment through a vein.
  • You have a serious active brain or nerve disorder; have had a seizure, stroke, or mini-stroke; or have uncontrolled diabetes, diabetes-related nerve damage, or a current hormone disorder.
  • You need oxygen at home or have had lung inflammation or scarring that needed steroid treatment throughout the body.
  • You have an active disease where the immune system attacks the body; have had an organ or donor stem cell transplant; or have had a major immune reaction to a medicine containing the antibody IgG.
  • You have a current or past skin disease needing frequent treatment; have had severe skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis; or are allergic to IDP-001 or its ingredients.
  • You have an active bleeding disorder, ongoing side effects from past cancer treatment, or another condition the study doctor thinks could affect your safety or the study.
  • You are in another clinical study during treatment, or you are pregnant, breastfeeding, or planning to become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (6)

CA

FL

IN

NY

TX