A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Trial ID: NCT06334432

Interventional - Phase 1/2 - Active, not recruiting

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.

Conditions

• Advanced Solid Tumor
• HER2-negative Breast Cancer
• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Pancreatic Cancer
• Platinum-resistant Ovarian Cancer (PROC)

Interventions

• NUV-1511

Eligibility

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

Sponsor

Nuvation Bio Inc.

Source: ClinicalTrials.gov

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