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 PARP inhibitor in people with advanced solid tumors. 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 prostate cancers only. 

Type of Study

This is an open-label 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 triple-negative breast cancer will receive either NUV-868 alone or in combination with the oral PARP inhibitor olaparib.
• Participants with pancreatic cancer will receive either NUV-868 alone or in combination of NUV-868 and the oral PARP inhibitor olaparib.
• Participants with ovarian cancer will receive either NUV-868 alone or in combination of NUV-868 and the oral PARP inhibitor olaparib.
• Participants with metastatic castration-resistant prostate cancer will one of the following:  NUV-868 alone, NUV-868 in combination with enzalutamide or NUV-868 in combination with olaparib.  
• Participants with solid tumors 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 solid tumors 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 metastatic cancers:

• triple-negative breast cancer
  • participants with a BRCA1 or BRCA2 mutation must have received PARP inhibitor treatment.
• platinum-resistant or platinum-refractive ovarian cancer
  • participants with a BRCA1 or BRCA2 mutation or a mutation associated with DNA-damage repair must have received PARP inhibitor treatment.
• pancreatic cancer
  • participants with a BRCA1 or BRCA2 mutation must have received PARP inhibitor treatment.
• castration-resistant prostate cancer
  • participants with a BRCA1 or BRCA2 mutation or a mutation associated with DNA-damage repair must have received PARP inhibitor treatment.

• People with cancer spread to their brain or central nervous system.
• People who are pregnant or breastfeeding.