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