A Phase 1/2 Open-label Study of IDP-001 in Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors

Study Identifier:
IDP-001-101
CT.gov Identifier:
NCT07602842
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Head & Neck
Solid Tumor
Digestive & Intestinal
Cervical cancer
Squamous Cell Carcinoma
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Salwan Al Mutar
Status
Will Be Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Head & Neck
Solid Tumor
Digestive & Intestinal
Cervical cancer
Squamous Cell Carcinoma
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Will Be Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Head & Neck
Solid Tumor
Digestive & Intestinal
Cervical cancer
Squamous Cell Carcinoma
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Head & Neck
Solid Tumor
Digestive & Intestinal
Cervical cancer
Squamous Cell Carcinoma