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

NCT06334432 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NUV-1511-01
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors

  Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities

  First 28 days of dosing (DLT evaluation period)

• Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))

  Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities

  First 28 days of dosing (DLT evaluation period)

• Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)

  Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI

  From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development

  Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)

  Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 2: Confirm the optimal NUV-1511 target tumor types for further development

  Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)

  Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

Secondary Outcomes (15)

• Phase 1: Explore preliminary efficacy of NUV-1511

  From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 1: Explore preliminary efficacy of NUV-1511

  From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 1: Explore preliminary efficacy of NUV-1511

  From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Characterize the PK profile of NUV-1511

  Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.

• Characterize the PK profile of NUV-1511

  Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.

Other Outcomes (10)

• Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis

  Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis

  Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

• Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity

  Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first

Study Arms (5)

Phase 1: Schedule A

OTHER

Schedule A evaluating escalating dose levels of NUV-1511

Drug: NUV-1511

Phase 1: Schedule B

OTHER

Schedule B evaluating escalating dose levels of NUV-1511

Drug: NUV-1511

Phase 2: Tumor Type 1

EXPERIMENTAL

Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.

Drug: NUV-1511

Phase 2: Tumor Type 2

EXPERIMENTAL

Tumor type to be selected after Phase 1. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1.

Drug: NUV-1511

Phase 2: All comers

EXPERIMENTAL

All tumor types allowed per protocol. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1.

Drug: NUV-1511

Interventions

NUV-1511 DRUG

Novel small molecule

Phase 1: Schedule A; Phase 1: Schedule B; Phase 2: All comers; Phase 2: Tumor Type 1; Phase 2: Tumor Type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

Study Sites (8)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

NEXT Oncology

Irving, Texas, 75038, United States

Location

START Mountain

Salt Lake City, Utah, 84124, United States

Location

NEXT Oncology

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 28, 2024
• Study Start: March 14, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (8)