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

Cancer Categories

Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic

Karmanos Trial ID

2024-008

NCT ID

NCT06334432

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Anthony
Shields, M.D., Ph.D.
Oncology - Medical View Profile

Objective:

PHASE 1

Primary Objectives:

Assess safety and tolerability of NUV‑1511 in advanced solid tumors
Identify recommended dosing schedule(s) and corresponding RP2D(s) for Phase 2

Secondary Objectives:

Explore preliminary efficacy of NUV-1511
Characterize the PK profiles of NUV-1511

PHASE 2

Primary Objectives:

Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
Confirm the optimal NUV-1511 dosing schedule, dose level, and target tumor types for further development

Secondary Objectives:

Further evaluate the safety and efficacy of NUV-1511

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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:

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
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

May have received up to 2 prior chemotherapies in mCRPC setting
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.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

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