Study on NUV-868 Alone and with Olaparib or Enzalutamide for Adults with Advanced Solid Tumors

Sponsor: Nuvation Bio Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05252390

Provider View

This clinical trial is testing a new drug, NUV-868, both by itself and in combination with other medications, to see if it is safe and effective for treating adults with advanced solid tumors. The study will help determine the best dose and treatment plan for future research.

Patient Parameters

Program Overview

The study is exploring a new treatment called NUV-868 for adults with advanced solid tumors. It will test NUV-868 alone and in combination with other drugs, olaparib or enzalutamide, to find out if it is safe and effective. The trial is divided into two phases. In the first phase, researchers will determine the safest dose of NUV-868, both alone and with the other drugs. In the second phase, they will test how well these treatments work. Participants will take NUV-868 by mouth daily in 28-day cycles, either alone or with the other drugs, until their disease progresses, they experience side effects, or they choose to stop.

Eligibility Criteria

Inclusion Criteria

Phase 1 (NUV-868 Alone)

  • Have advanced solid tumors that have worsened after standard treatments or have no other effective treatment options.
  • Expected to live for more than 3 months.
  • Be in good overall health with a performance status of 2 or less, meaning able to carry out light work.
  • Have measurable or non-measurable disease.

Phase 1b (NUV-868 with Enzalutamide or Olaparib)

  • Expected to live for more than 3 months.
  • Be in good overall health with a performance status of 2 or less.
  • For some groups, have measurable disease.
  • Be able to document food intake and medication use, or have a caregiver to assist.
  • Have one of the following cancer types:
    • Ovarian: Resistant to platinum-based treatments and in relapse.
    • Pancreatic: Progressed after at least one chemotherapy treatment.
    • Prostate: Metastatic cancer that has progressed after treatment.
    • Breast: Triple-negative breast cancer that has progressed after treatment.
    • Other advanced tumors (for dose escalation with NUV-868 + olaparib): Must be approved by the study Medical Monitor.
    • All tumor types: Eligible regardless of BRCA/HRR status.

Phase 2

  • Expected to live for more than 6 months.
  • For some groups, have at least one measurable tumor.
  • Be in very good overall health with a performance status of 1 or less.
  • Have one of the following cancer types:
    • Ovarian: Resistant to platinum-based treatments and in relapse.
    • Pancreatic: Progressed after at least one chemotherapy treatment.
    • Prostate: Metastatic cancer that has progressed after treatment.
    • Breast: Triple-negative breast cancer that has progressed after treatment.

Exclusion Criteria

  • Have received chemotherapy, hormonal therapy (except for ongoing hormone therapy in men and premenopausal women), radiation, or biological anticancer therapy within 14 days before starting NUV-868.
  • Have taken an investigational drug within 14 days (for non-myelosuppressive drugs) or within 21 days or less than 5 half-lives (whichever is longer) for myelosuppressive drugs before starting the study treatment.
  • Need medications that strongly affect certain liver enzymes (CYP3A4/5), which can interfere with the study drugs.
  • Female patients who are pregnant or breastfeeding.

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