Study Stopped
The Sponsor has achieved its objectives.
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
1 other identifier
interventional
82
2 countries
22
Brief 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(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2022
CompletedFirst Posted
Study publicly available on registry
February 23, 2022
CompletedStudy Start
First participant enrolled
March 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2024
CompletedNovember 6, 2025
November 1, 2025
2.3 years
January 28, 2022
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Phase 1 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)
Incidence of dose-limiting toxicities (DLTs)
During the DLT period (28 days)
Phase 1b Dose Escalation, NUV-868 + Olaparib: Safety and tolerability of NUV-868 in combination with olaparib to determine the recommended Phase 2 combination dose (RP2cD)
Incidence of DLTs
During the DLT period (28 days)
Phase 1b Dose Escalation, NUV-868 + Olaparib: Pharmacokinetic (PK) profiles of NUV-868 and olaparib when administered in combination
NUV-868 and olaparib combination PK
Days 1, 8, and 29
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD
Incidence of DLTs
During the DLT period (28 days)
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination
NUV-868 and enzalutamide combination PK
Days 1, 8, and 57
Phase 2, NUV-868 + Olaparib: Change from Baseline in Tumor Imaging
ORR per standard criteria
Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
Phase 2, NUV-868 + Olaparib: Change from Baseline in PSA measurements
PSA50 response rate per standard criteria; only for patients with prostate cancer
Every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)
Phase 2, NUV-868 + Enzalutamide in Enzalutamide-Naïve Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Time from First Dose to Disease Progression
Radiographic progression-free survival (rPFS) per standard criteria
Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
Phase 2, NUV-868 + Enzalutamide in Enzalutamide-Resistant mCRPC: Response to Study Treatment
Composite response rate (CRR: radiologic response, PSA50 response, and/or circulating tumor cell response) per standard criteria
Every 4-12 weeks (time points vary depending on the type of response being evaluated) throughout study treatment, up to an average of 12 months (end of treatment)
Phase 1b Food Effect Substudy: Effect of Food on the Pharmacokinetics (PK) of NUV-868
NUV-868 PK parameters in fed and fasted states
Pre dose and 24 hours after the first and second doses of NUV-868, 7 days apart
Study Arms (7)
Phase 1 Monotherapy
EXPERIMENTALNUV-868 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached or a recommended Phase 2 dose (RP2D) is determined.
Phase 1b Combination: NUV-868 + Olaparib
EXPERIMENTALNUV-868 will be administered at escalating dose levels in combination with olaparib until the recommended Phase 2 combination dose (RP2cD) is determined. 300 mg olaparib will be administered orally twice daily throughout the 28-day cycles of NUV-868.
Phase 1b Combination: NUV-868 + Enzalutamide
EXPERIMENTALNUV-868 will be administered daily at escalating dose levels in combination with enzalutamide until the RP2cD is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-868.
Phase 2 Combination: NUV-868 + Olaparib
EXPERIMENTALNUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.
Phase 2 Combination: NUV-868 + Enzalutamide
EXPERIMENTALNUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.
Phase 2: NUV-868 Monotherapy
EXPERIMENTALNUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Phase 2: Enzalutamide Monotherapy
ACTIVE COMPARATOR160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Interventions
NUV-868 is an investigational drug for oral dosing.
Olaparib
Enzalutamide
Eligibility Criteria
You may qualify if:
- Recovered from toxicity to prior anticancer therapy
- Adequate bone marrow and organ function
- No known active or symptomatic central nervous system (CNS) disease
- 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
- +14 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
The University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Ellison Institute of Technology
Los Angeles, California, 90064, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Macquarie University Hospital
North Ryde, New South Wales, 2109, Australia
Calvary Mater Hospital Newcastle
Waratah, New South Wales, 2298, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2022
First Posted
February 23, 2022
Study Start
March 29, 2022
Primary Completion
July 15, 2024
Study Completion
July 15, 2024
Last Updated
November 6, 2025
Record last verified: 2025-11