Safety And Efficacy Study Of NUV-1511 In Adult Patients With Advanced Solid Tumors

Study Overview

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

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.

N/A

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

DRUG: NUV-1511

NUV-1511-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-09-13
First Submitted that Met QC Criteria 2024-03-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-09-19
First Posted (ACTUAL) 2024-03-28	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Phase 1: Schedule A Schedule A evaluating escalating dose levels of NUV-1511	DRUG: NUV-1511 Novel small molecule
OTHER: Phase 1: Schedule B Schedule B evaluating escalating dose levels of NUV-1511	DRUG: NUV-1511 Novel small molecule
EXPERIMENTAL: Phase 2: Tumor Type 1 Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.	DRUG: NUV-1511 Novel small molecule
EXPERIMENTAL: Phase 2: Tumor Type 2 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 Novel small molecule
EXPERIMENTAL: Phase 2: All comers 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 Novel small molecule

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Phase 1: Explore preliminary efficacy of NUV-1511	Overall response rate and duration of response per RECIST 1.1. 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 1: Explore preliminary efficacy of NUV-1511	Overall response rate and duration of response per composite response rate (for mCRPC). 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 1: Explore preliminary efficacy of NUV-1511	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.	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	Parameters include, but not limited to, maximum observed plasma concentration (Cmax)	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	Parameters include, but not limited to, area under the plasma concentration-time curve (AUC)	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.
Phase 2: Further evaluate the safety and efficacy of NUV-1511	Incidence of TEAEs and SAEs	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 2: Further evaluate the safety and efficacy of NUV-1511	Laboratory abnormalities	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 2: Further evaluate the safety and efficacy of NUV-1511	Duration of response	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 2: Further evaluate the safety and efficacy of NUV-1511	Clinical best response	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 2: Further evaluate the safety and efficacy of NUV-1511	Progression free survival	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 2: Further evaluate the safety and efficacy of NUV-1511	Overall survival	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 2: Further evaluate the safety and efficacy of NUV-1511	PK exposure-response modeling, which includes measuring plasma concentration versus overall response rate	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 2: Further evaluate the safety and efficacy of NUV-1511	PK exposure-response modeling, which includes measuring plasma concentration versus progression free survival	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 2: Further evaluate the safety and efficacy of NUV-1511	PK exposure-response modeling, which includes measuring plasma concentration versus treatment emergent adverse events and serious adverse events.	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 2: Further evaluate the safety and efficacy of NUV-1511	Response rates in disease-specific markers	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nuvation Bio

Phone Number: 332-208-6102

Email: clinicaltrials@nuvationbio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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

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

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

Collaborators and Investigators

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