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

November 4, 2025 updated by: Nuvation Bio Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study was initially planned as a Phase 1/2 study; however, the study stopped early prior to the start of Phase 2.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • North Ryde, New South Wales, Australia, 2109
        • Macquarie University Hospital
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Hospital Newcastle
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90064
        • Ellison Institute of Technology
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers, LLP
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria For All Phases and Cohorts:

  1. Recovered from toxicity to prior anticancer therapy
  2. Adequate bone marrow and organ function
  3. 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)

  1. 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
  2. Life expectancy of > 3 months
  3. Eastern Cooperative Oncology Group Performance Status ≤ 2
  4. Measurable or non-measurable disease

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

  1. Life expectancy of > 3 months
  2. Eastern Cooperative Oncology Group Performance Status ≤ 2
  3. (Select cohorts only) Measurable disease
  4. 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.

  5. One of the following tumor types:

    1. Ovarian: Platinum-resistant OR platinum-refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
    2. Pancreatic: Pancreatic ductal adenocarcinoma (PDAC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    3. 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
    4. Breast: Triple-negative breast cancer (TNBC) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    5. Other advanced tumors (only Phase 1b dose escalation, NUV-868 + olaparib): the study Medical Monitor must approve enrollment.
    6. For all tumor types: Patients will be allowed in the study regardless of their BRCA/HRR status.

Phase 2

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

  4. One of the following tumor types:

    1. Ovarian: Platinum-resistant or platinum- refractory high grade serous ovarian, fallopian, or primary peritoneal cancer in the relapsed setting
    2. Pancreatic: Progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting
    3. 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
    4. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Female patients who are pregnant of breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Monotherapy
NUV-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.
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Experimental: Phase 1b Combination: NUV-868 + Olaparib

NUV-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.
Drug: Olaparib
Olaparib
Other Names:
  • Lynparza
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Experimental: Phase 1b Combination: NUV-868 + Enzalutamide

NUV-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.
Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Experimental: Phase 2 Combination: NUV-868 + Olaparib

NUV-868 will be administered at the RP2cD.

Olaparib will be administered at the RP2cD.
Drug: Olaparib
Olaparib
Other Names:
  • Lynparza
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Experimental: Phase 2 Combination: NUV-868 + Enzalutamide

NUV-868 will be administered at the RP2cD.

Enzalutamide will be administered at the RP2cD.
Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Experimental: Phase 2: NUV-868 Monotherapy
NUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Drug: NUV-868
NUV-868 is an investigational drug for oral dosing.
Active Comparator: Phase 2: Enzalutamide Monotherapy
160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)
Time Frame: During the DLT period (28 days)
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)
Time Frame: During the DLT period (28 days)
Incidence of DLTs
During the DLT period (28 days)
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD
Time Frame: During the DLT period (28 days)
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
Time Frame: Days 1, 8, and 29
NUV-868 and olaparib combination PK
Days 1, 8, and 29
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination
Time Frame: Days 1, 8, and 57
NUV-868 and enzalutamide combination PK
Days 1, 8, and 57
Phase 2, NUV-868 + Olaparib: Change from Baseline in Tumor Imaging
Time Frame: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
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
Time Frame: Every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)
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
Time Frame: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
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
Time Frame: 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)
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
Time Frame: Pre dose and 24 hours after the first and second doses of NUV-868, 7 days apart
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvation Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUV-868-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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