Study on the Safety and Effectiveness of NUV-1511 for Adults with Advanced Solid Tumors

Sponsor: Nuvation Bio Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06334432

This clinical trial is testing a new drug, NUV-1511, to see if it is safe and effective for treating adults with advanced solid tumors. The study is divided into two phases: Phase 1 focuses on safety and tolerability, while Phase 2 evaluates how well the drug works.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment, NUV-1511, for adults with advanced solid tumors. In Phase 1, researchers will determine if the drug is safe and what doses are tolerable. In Phase 2, they will assess how effective NUV-1511 is in treating these tumors. Participants will receive the drug and undergo various tests to monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have advanced solid tumors, such as:
    • HER2-negative metastatic breast cancer that has worsened after certain treatments.
    • Metastatic castration-resistant prostate cancer (mCRPC) with specific prior treatments.
    • Pancreatic cancer that has progressed after chemotherapy.
    • Platinum-resistant high-grade serous ovarian, fallopian, or primary peritoneal cancer.
  • Have measurable disease according to specific medical criteria.
  • Have advanced solid tumors that have worsened after approved treatments or have no standard effective therapy available.
  • Have adequate bone marrow and organ function.
  • Be willing to provide informed consent and comply with study requirements.

Exclusion Criteria

  • Have received chemotherapy, hormonal therapy, radiation, or biological anticancer therapy within 14 days before starting the study treatment.
  • Have taken an investigational drug within 14 days before starting the study treatment.
  • Have an ongoing or active infection requiring treatment or hospitalization within 2 weeks before starting the study treatment.
  • Have a heart function below 50% as measured by specific tests.
  • Have a history of significant heart disease or unstable heart conditions.
  • Have an uncontrolled immunosuppressive disease or active autoimmune disease.
  • Have had major surgery within 2 weeks before starting the study treatment or need major surgery during the study.
  • Have another cancer within 2 years before starting the study treatment that could affect survival or tumor assessments.
  • Be pregnant or breastfeeding.

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