Breast Cancer Clinical Trial

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Summary

NUV-868-01 is a first-in-human, open-label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and 2b portions. In these Phase 2 portions, NUV-868 as a monotherapy (Phase 2) or in combination with olaparib or enzalutamide (Phase 2b) will be given to determine the safety and efficacy of these study treatments. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2b, patients will self-administer NUV-868 orally daily in 28-day cycles with either 300 mg olaparib twice daily or 160 mg enzalutamide daily. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria For All Phases and Cohorts:

Recovered from toxicity to prior anticancer therapy
Adequate bone marrow and organ function
No known active or symptomatic central nervous system (CNS) disease

Cohort-Specific Inclusion Criteria: In addition to the inclusion criteria listed above, the following criteria apply for enrollment into specific cohorts.

Phase 1 (NUV-868 Monotherapy)

Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available
Life expectancy of > 3 months
Eastern Cooperative Oncology Group Performance Status ≤ 2
Measurable or non-measurable disease

Phase 1b (NUV-868 in Combination With Enzalutamide or Olaparib)

Life expectancy of > 3 months
Eastern Cooperative Oncology Group Performance Status ≤ 2
(Select cohorts only) Measurable disease
Patient must be able to read and write sufficiently to document food intake and study drug dosing on the Dosing Diary or must have a caregiver who is willing and able to complete the Dosing Diary with the patient.

One of the following tumor types:

Ovarian: Platinum-resistant OR platinum-refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
Pancreatic: Pancreatic ductal adenocarcinoma (PDAC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting
Breast: Triple-negative breast cancer (TNBC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
Other advanced tumors (only Phase 1b dose escalation, NUV-868 + olaparib): the study Medical Monitor must approve enrollment.
For all tumor types: Patients will be allowed in the study regardless of their BRCA/HRR status.

Phase 2

Life expectancy of > 6 months
(Select cohorts only): At least one measurable lesion defined by standard criteria
Eastern Cooperative Oncology Group Performance Status ≤ 1

One of the following tumor types:

Ovarian: Platinum-resistant or platinum- refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
Pancreatic: Progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
Prostate: Histologically confirmed, metastatic adenocarcinoma of the prostate (adenocarcinoma/high grade carcinoma with neuroendocrine features is allowed) with progression on or after treatment with at least one NHT in the metastatic setting
Breast: TNBC with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting

Key Exclusion Criteria For All Phases and Cohorts:

Have received chemotherapy, hormonal therapy (except for ongoing luteinizing hormone-releasing hormone [LHRH] analogs in male patients and premenopausal women), radiation, or biological anticancer therapy within 14 days prior to the first dose of NUV-868.
Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent, or within 21 days or < 5 half-lives (whichever is longer) for myelosuppressive agent, prior to the first dose of study treatment.
Requires medications that are known to be strong (or moderate for olaparib) inducers and/or strong (or moderate for olaparib) inhibitors of CYP3A4/5 enzymes.
Female patients who are pregnant of breastfeeding.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

657

Study ID:

NCT05252390

Recruitment Status:

Recruiting

Sponsor:

Nuvation Bio Inc.

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There are 30 Locations for this study

See Locations Near You

The University of Arizona Cancer Center
Tucson Arizona, 85724, United States More Info
Tera Hennson
Contact
520-626-1347
[email protected]
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles California, 90064, United States More Info
Mitchell Gross, MD
Contact
310-272-7640
[email protected]
Nicole Rudin
Contact
310-272-7640
[email protected]
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Jericho Rabago
Contact
949-764-6796
[email protected]
Jason Ledesma
Contact
949-764-4577
[email protected]
Rocky Mountain Cancer Centers, LLP
Aurora Colorado, 80012, United States More Info
Jennifer Hege, RN
Contact
303-385-2067
[email protected]
Rocky Mountain, Cancer Centers, LLP
Denver Colorado, 80218, United States More Info
Jennifer Hege, RN
Contact
303-385-2067
[email protected]
Rocky Mountain Cancer Centers, LLP
Lone Tree Colorado, 80124, United States More Info
Jennifer Hege, RN
Contact
303-385-2067
[email protected]
Tampa General Hospital Cancer Center of South Florida
Tampa Florida, 33606, United States More Info
Alexa Steinbrueck
Contact
813-844-8814
[email protected]
Marlene Martin
Contact
813-844-5012
[email protected]
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Robin Neubauer
Contact
813-745-1771
[email protected]
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States More Info
John Torreverde
Contact
410-955-1057
[email protected]
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Xin Gao, MD
Contact
617-724-4000
[email protected]
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
St. Vincent-Frontier Cancer Center
Billings Montana, 59102, United States More Info
Patrick Cobb, MD, FACO
Contact
406-238-6290
Tina Erhardt
Contact
406-238-6962
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Salome Geene
Contact
973-971-6373
[email protected]
Atlantic Health System / Overlook Medical Center
Summit New Jersey, 07901, United States More Info
Salome Greene
Contact
973-971-6373
[email protected]
Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
New York New York, 10016, United States More Info
Dayna Leis, RN
Contact
347-266-2630
[email protected]
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Wassim Abida, MD
Contact
646-422-4600
[email protected]
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States More Info
Ashley McClain
Contact
980-441-1021
[email protected]
Abramson Cancer Center of the U of Penn.
Philadelphia Pennsylvania, 19104, United States More Info
Jennifer Louie
Contact
267-414-6179
[email protected]
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Jennifer Luhmann
Contact
215-728-4753
[email protected]
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Jennifer Louie
Contact
[email protected]
Kim Reiss Binder, MD
Principal Investigator
Sarah Cannon Research Institute - Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Douglas Orr, MD
Contact
972-566-3000
[email protected]
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Christine Terraciano
Contact
214-370-1942
[email protected]
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States More Info
Nori Sullivan, RN
Contact
817-413-1760
[email protected]
Center for Oncology and Blood Disorders
Houston Texas, 77030, United States More Info
Luis Camacho, MD
Contact
713-301-8964
[email protected]
Johnathan Ojo
Contact
832-540-1951
[email protected]
NEXT Virginia
Fairfax Virginia, 22031, United States More Info
Valerie Strickland
Contact
210-580-9500
[email protected]
Virginia Oncology Associates
Norfolk Virginia, 23502, United States More Info
Wendi Gobhardt
Contact
757-213-5813
[email protected]
Macquarie University Hospital
North Ryde New South Wales, 2109, Australia More Info
Callum Rutherford
Contact
61 2 9812 2959
[email protected]
Calvary Mater Hospital Newcastle
Waratah New South Wales, 2298, Australia More Info
Howard Chan
Contact
61 2 4014 3563
[email protected]
Saba Kugashiya
Contact
61 2 4014 3291
[email protected]
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia More Info
Shehara Mendis
Contact
1300 300 977
[email protected]
Dina Cherfi
Contact
61 3 9508 3596
[email protected]
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia More Info
Richelle Linklater
Contact
61 3 8559 5000
[email protected]
Linear Clinical Research
Nedlands Western Australia, 6009, Australia More Info
Michael Millward
Contact
+61(0)419395975
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

657

Study ID:

NCT05252390

Recruitment Status:

Recruiting

Sponsor:


Nuvation Bio Inc.

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