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NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced Solid Tumors
Clinicaltrials.gov identifier:
NCT05252390
Treatment
Treatment study for people with advanced solid tumors, including triple-negative breast, ovarian, pancreatic and prostate cancer
Study Contact Information:
Clinical Trials at Nuvation Bio by phone: 332-208-6102
or by email: ClinicalTrials@nuvationbio.com
NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced Solid Tumors
About the Study
This study will test how safe and effective the experimental drug NUV-868 is by itself and in combination with a in people with advanced . The first part of the study will include people with any solid tumor type, and the second part will include people with triple-negative breast, ovarian, pancreatic or cancers only.
Type of Study
This is an study, meaning participants and their doctors will know which drug(s) are being given. The study will be run in different phases and will have different groups. The dose and combination of treatments participants receive will depend on their cancer type and when they enroll in the study.
What the Study Involves
This study will have different phases and groups.
All participants will receive the study drug NUV-868. The dose will vary based on when people enroll in the study. Some participants will receive a second drug in combination with NUV-868. The combination will depend on their cancer type and when they enrolled in the study.
- Participants with will receive either NUV-868 alone or in combination with the oral olaparib.
- Participants with pancreatic cancer will receive either NUV-868 alone or in combination of NUV-868 and the oral olaparib.
- Participants with ovarian cancer will receive either NUV-868 alone or in combination of NUV-868 and the oral olaparib.
- Participants with castration-resistant cancer will one of the following: NUV-868 alone, NUV-868 in combination with enzalutamide or NUV-868 in combination with olaparib.
- Participants with other than those listed above, may enroll in Phase 1 of the study only. These participants will receive NUV-868 alone.
Participants will continue treatment unless their cancer gets worse, they develop serious side-effects, they decide to stop participating or the study is stopped.
The duration of the trial is expected to be 12 months.
Study Sites
Maryland
- Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact: John Torreverde by phone: 410-955-1057 or by email: jtorrev1@jhmi.edu
Michigan
- Detroit
Karmanos Cancer Institute - Contact: Sarah Grace by phone: 313-576-9806 or by email: graces@karmanos.org
North Carolina
- Huntersville
Carolina BioOncology Institute
Contact: Ashley McClain by phone: 980-441-1021 or by email: AMcClain@carolinabiooncology.org
Virginia
- Fairfax
NEXT Virginia
Contact: Valerie Strickland by phone: 210-580-9500 vstrickland@nextoncology.com
Phase 1 is open to people with advanced whose cancer has progressed during or after treatment with approved therapies or for which there is no standard effective treatment available.
Phase 2 is open to people diagnosed with the following advanced or cancers:
- triple-negative breast cancer
- participants with a or mutation must have received treatment.
- platinum-resistant or platinum-refractive ovarian cancer
- participants with a or mutation or a mutation associated with DNA-damage repair must have received treatment.
- pancreatic cancer
- participants with a or mutation must have received treatment.
- castration-resistant cancer
- participants with a or mutation or a mutation associated with DNA-damage repair must have received treatment.
- People with cancer spread to their brain or central nervous system.
- People who are pregnant or breastfeeding.