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Trial Title: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

NCT ID: NCT06334432

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

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: NUV-1511
Description: Novel small molecule
Arm group label: Phase 1: Schedule A
Arm group label: Phase 1: Schedule B
Arm group label: Phase 2: All comers
Arm group label: Phase 2: Tumor Type 1
Arm group label: Phase 2: Tumor Type 2

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Karmanos Cancer Center

Address:
City: Detroit
Zip: 48201
Country: United States

Status: Recruiting

Contact:
Last name: Anthony Shields, MD

Phone: 313-576-8734
Email: shielda@karmanos.org

Contact backup:
Last name: Zuccaro Clarice

Phone: 313-576-9375
Email: zuccaroc@karmanos.org

Investigator:
Last name: Anthony Shields, MD
Email: Principal Investigator

Facility:
Name: Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Status: Recruiting

Contact:
Last name: Martin Gutierrez, Principal Investigator, MD

Phone: 551-996-5463
Email: Martin.Gutierrez@hmhn.org

Facility:
Name: Memorial Sloan-Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Shanu Modi, MD

Phone: 646-888-4564
Email: modis@mskcc.org

Investigator:
Last name: Shanu Modi, MD
Email: Principal Investigator

Facility:
Name: Carolina BioOncology Institute

Address:
City: Huntersville
Zip: 28078
Country: United States

Status: Recruiting

Contact:
Last name: Neel Gandhi, MD
Email: nghandhi@carolinabiooncology.org

Contact backup:
Last name: Lindsay Davis
Email: ldavis@carolinaoncology.org

Investigator:
Last name: Neel Gandhi, MD
Email: Principal Investigator

Facility:
Name: NEXT Oncology

Address:
City: Irving
Zip: 75038
Country: United States

Status: Recruiting

Contact:
Last name: Naga Koteswari Cheedella

Phone: 214-645-4673
Email: ncheedella@nextoncology.com

Facility:
Name: START Mountain

Address:
City: Salt Lake City
Zip: 84124
Country: United States

Status: Recruiting

Contact:
Last name: William McKean

Phone: 801-581-2121
Email: William.McKean@hci.utah.edu

Facility:
Name: NEXT Oncology

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Contact:
Last name: Alex Spira

Phone: 210-580-9500
Email: aspira@nextoncology.com

Facility:
Name: Fred Hutchinson

Address:
City: Seattle
Zip: 98109
Country: United States

Status: Recruiting

Contact:
Last name: Lynn Symonds, Principal Investigator, MD

Phone: 206-606-7017
Email: lynnsym@uw.edu

Contact backup:
Last name: Rajee Pandey

Phone: 2066064726
Email: rajee21@fredhutch.org

Start date: March 14, 2024

Completion date: October 2027

Lead sponsor:
Agency: Nuvation Bio Inc.
Agency class: Industry

Source: Nuvation Bio Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06334432

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