A Phase I/II, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Study Identifier:
NUV-1511-01
CT.gov Identifier:
NCT06334432
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

To evaluate safety and tolerability, and explore the potential for clinical efficacy of NUV-1511 in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Breast Cancers
  • Prostate
  • Pancreas
  • Ovarian
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Phase 1: Schedule A
    • Read More
  • Drug: Phase 1: Schedule B
  • Drug: Experimental: Phase 2: Tumor Type 1
  • Drug: Experimental: Phase 2: Tumor Type 2
  • Drug: Experimental: Phase 2: All comers
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • - Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor
    • Type-Specific cohort(s): must meet one of the following criteria:
    • - HER2- metastatic breast cancer:
    • 1. Hormone refractory hormone receptor positive metastatic breast cancer with
    • progression on or after treatment with CDK4/6 inhibitor plus at least one line of
    • systemic chemotherapy in the advanced setting
    • 2. Triple negative metastatic breast cancer with progression after at one line of
    • systemic chemotherapy in the advanced setting.
    • - Patients with advanced solid tumors that progressed on or following treatment with
    • Enhertu and/or Trodelvy per label
    • - mCRPC: Histologically confirmed, metastatic castration resistant adenocarcinoma of the
    • prostate
    • 1. May have received up to 2 prior chemotherapies in mCRPC setting
    • 2. Prior therapy with PARP (poly-ADP ribose polymerase) inhibitor, PLUVICTO,
    • Radium-223, or Provenge is allowed
    • - Pancreatic cancer: PDAC (pancreatic ductal adenocarcinoma) with progression on or
    • after treatment with at least one line of systemic chemotherapy in the advanced
    • setting.
    • - PROC: Histologically or cytologically confirmed platinum-resistant high-grade serous
    • ovarian, fallopian, or primary peritoneal cancer;
    • - Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor
    • Type-Specific cohorts (except mCRPC; see inclusion criterion 2 above): must have
    • measurable disease per RECIST 1.1
    • - Phase 2 All Comers cohort: Patients with advanced solid tumors that have progressed
    • during or after treatment with approved therapies or for whom there is no standard
    • effective therapy available.
    • - Adequate bone marrow and organ function.
    • - Provide informed consent, which includes compliance with protocol-specified
    • requirements and restrictions
    Exclusion criteria
    • - Chemotherapy, hormonal therapy (with the exception of ongoing luteinizing
    • hormone-releasing hormone analogs in male patients and premenopausal females),
    • radiation therapy, or biological anticancer therapy within 14 days before the first
    • dose of study treatment
    • - Treatment with an investigational agent for any indication within 14 days before the
    • first dose of study treatment for non-myelosuppressive agent, or within 21 days or <5
    • half-lives before the first dose of study treatment, whichever is longer, for a
    • myelosuppressive agent
    • - Ongoing or active infection requiring systemic therapy, or an infection requiring
    • hospitalization or intravenous therapy within 2 weeks before the first dose of study
    • treatment
    • - Resting left ventricular ejection fraction (LVEF) of <50% obtained by echocardiography
    • or multigated acquisition scan (MUGA)
    • - History of significant cardiac disease, including myocardial infarction, New York
    • Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac
    • arrhythmias (eg, ventricular tachycardia, ventricular fibrillation), syncope of
    • cardiovascular etiology, or cardiac arrest:
    • - Known immunosuppressive disease or active systemic autoimmune disease such as systemic
    • lupus erythematosus, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or
    • hepatitis C virus (HCV) infections not currently controlled by current
    • disease-specific therapy. The following exceptions apply:
    • - Major surgical procedure within 2 weeks before the first dose of study treatment, or
    • an anticipated need for major surgery during the course of the study
    • - Other cancer within 2 years before the first dose of study treatment with metastatic
    • or local recurrence potential that could negatively impact survival and/or potentially
    • confound tumor response assessments. Patients with a history of other cancers in the
    • past 2 years should be discussed with the Medical Monitor.
    • - Female patients who are pregnant or breastfeeding

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Solid Tumor
    Breast Cancers
    Prostate
    Pancreas
    Ovarian