Study on OBI-992 for Adults with Advanced Solid Tumors

Sponsor: OBI Pharma, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06480240

Provider View

This clinical trial is testing a new drug, OBI-992, to find the best dose and understand its safety and effects in adults with advanced solid tumors. The study is divided into two parts: the first part focuses on finding the right dose, and the second part looks at how well the drug works and its safety.

Patient Parameters

Program Overview

This study is exploring a new treatment called OBI-992 for adults with advanced solid tumors that cannot be cured with local treatments. The trial has two parts: Part A aims to find the safest and most effective dose of OBI-992, while Part B will further investigate the drug's safety and how well it works in treating these tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Must agree to participate and sign a consent form.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be cured with local treatments.
  • Have tried standard treatments, or doctors have determined these treatments are not effective, or have chosen not to receive standard treatments.
  • Have at least one tumor that can be measured.
  • Be in good overall health, with a performance status score of 0 or 1.
  • Have adequate liver, kidney, and blood function based on specific medical tests.
  • Be willing to follow all study procedures, including providing a tumor sample.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after the last dose. Men must also agree to use contraception during the study and for 120 days after the last dose.
  • Cannot be breastfeeding.
  • HIV-positive individuals can participate if their condition is stable and controlled.
  • Individuals with hepatitis B or C can participate if their viral load is low or undetectable.
  • For Part B, must have one of the following cancers: non-small cell lung cancer, small cell lung cancer, or gastric cancer.

Exclusion Criteria

  • Have had chemotherapy or radiation therapy within the last 3 weeks, or biologic therapy within 5 half-lives or 3 weeks, whichever is shorter.
  • Have had major surgery or a significant injury within the last 28 days.
  • Have severe nerve damage.
  • Have had a solid organ transplant.
  • Have unresolved side effects from previous cancer treatments, except for hair loss and certain lab values.
  • Have a prolonged QT interval on an ECG test.
  • Have an allergy to OBI-992 or its ingredients.
  • Have untreated brain metastases. Treated brain metastases are allowed if stable for at least 4 weeks.
  • Have significant heart problems.
  • Have any life-threatening medical conditions or conditions that could interfere with the study.
  • For Part B, cannot have had prior treatment with a TROP2 ADC, except during dose escalation.
  • Are taking any prohibited medications.

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