Study on the Safety and Effectiveness of ENV-501 for Patients with HER3-Positive Solid Tumors

Inclusion Criteria

• Weigh at least 40 kg (about 88 pounds).
• Agree to sign a consent form to participate in the study.
• Have a confirmed diagnosis of advanced or metastatic HER3-positive solid tumors that have not responded to standard treatments or for which no standard treatment is available. This includes:
  • Unresectable or metastatic skin melanoma (HER3+)
  • Advanced or metastatic lung cancer with specific mutations (HER3+)
  • Advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative (HER3+)
• If no test confirms HER3 status, agree to a new tumor biopsy.
• Be in good general health with an ECOG performance status of 0 to 2.
• Women who can become pregnant must use birth control starting 28 days before the study, during the study, and for 6 months after the last dose.
• Men must use condoms with spermicide during the study and for 6 months after the last dose.
• Women must agree not to donate eggs or breastfeed during the study and for 6 months after.
• Men must agree not to donate sperm or father a child during the study and for 6 months after.
• Be willing to attend all study visits and follow the treatment plan.

Exclusion Criteria

• Have received any cancer treatment within 21 days before starting the study.
• Have taken investigational drugs within 21 days before starting the study.
• Have had major surgery within 21 days before starting the study.
• Have had radiation therapy within 4 weeks before starting the study.
• Have had a stem cell or organ transplant within 3 months before starting the study.
• Are taking certain medications that affect how the body processes drugs.
• Have previously been treated with a HER3-targeted therapy or certain other cancer drugs.
• Have a primary immune deficiency or active, uncontrolled infections.
• Have allergies to ENV-501 or similar drugs.
• Have a history of lung disease or pneumonitis.
• Test positive for HIV, hepatitis B, or hepatitis C, unless cured.
• Have active brain metastases or leptomeningeal disease.
• Are pregnant or have a positive pregnancy test.
• Have another active cancer requiring treatment.
• Are a close family member of someone involved in the study.