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

Phase 1

Recruiting

• Conditions: Pancreatic Cancer; Metastatic Castration-resistant Prostate Cancer (mCRPC); Advanced Solid Tumor; Platinum-resistant Ovarian Cancer (PROC); HER2-negative Breast Cancer
• Interventions: Drug: NUV-1511

• Registration Number: NCT06334432
• Lead Sponsor: Nuvation Bio Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study Start: 2024-03-14
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2027-03
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 466

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: Schedule A	NUV-1511	Schedule A evaluating escalating dose levels of NUV-1511
Phase 2: Tumor Type 1	NUV-1511	Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.
Phase 2: Tumor Type 2	NUV-1511	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.
Phase 1: Schedule B	NUV-1511	Schedule B evaluating escalating dose levels of NUV-1511
Phase 2: All comers	NUV-1511	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.

Primary Outcome Measures

Name	Time	Method
Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development	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	Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))	First 28 days of dosing (DLT evaluation period)	Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)	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	Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
Phase 2: Confirm the optimal NUV-1511 target tumor types for further development	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	Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors	First 28 days of dosing (DLT evaluation period)	Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities

Secondary Outcome Measures

Name	Time	Method
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.	Parameters include, but not limited to, area under the plasma concentration-time curve (AUC)
Phase 2: Further evaluate the safety and efficacy of NUV-1511	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	Response rates in disease-specific markers
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	Overall response rate and duration of response per response rates in specific disease markers. Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.

Trial Locations

Locations (7)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Fred Hutchinson; 🇺🇸 Seattle, Washington, United States

Karmanos Cancer Center; 🇺🇸 Detroit, Michigan, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Carolina BioOncology Institute; 🇺🇸 Huntersville, North Carolina, United States

NEXT Oncology; 🇺🇸 Fairfax, Virginia, United States

START Mountain; 🇺🇸 Salt Lake City, Utah, United States