A Study of IDP-001 in Advanced or Metastatic Solid Tumors

Korábbi kezelés

• 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

Más betegség

• 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.

Egyéb

• Requires home oxygen
• Pregnant or lactating or planning to become pregnant
• Current endocrinopathy

• 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