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Advanced Solid TumorPhase 1NCT05252390

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

A Phase 1 study testing NUV-868, Olaparib and Enzalutamide in people with Advanced Solid Tumor and Ovarian Cancer, run by Nuvation Bio Inc. at 22 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Ovarian Cancer, Ovary Cancer
What is being tested?
NUV-868, Olaparib and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
22 sitesin 2 countries
Study dates
29 Mar 2022to 15 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United States17 sites

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree, Colorado, 80124

  • Ellison Institute of Technology

    Los Angeles, California, 90064

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee, 37203

  • Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19104

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Australia5 sites

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Macquarie University Hospital

    North Ryde, New South Wales, 2109

  • Calvary Mater Hospital Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
NUV-868, Olaparib, Enzalutamide
Keywords
Phase 1, Phase 2, NUV-868, olaparib, enzalutamide, Xtandi, ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer, triple-negative breast cancer, Lynparza, PARP inhibitor, BET inhibitor, BRCA mutation, BRCA1, BRCA2, HRD, HRR deficiency, homologous recombination deficiency
Medical subject headings
Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUV-868Drug

    NUV-868 is an investigational drug for oral dosing.

  • OlaparibDrug

    Also called Lynparza

    Olaparib

  • EnzalutamideDrug

    Also called Xtandi

    Enzalutamide

Study groups in NCT05252390
Study groupRoleWhat they receive
Phase 1 MonotherapyExperimentalNUV-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.
Receives: Drug: NUV-868
Phase 1b Combination: NUV-868 + OlaparibExperimentalNUV-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.
Receives: Drug: NUV-868; Drug: Olaparib
Phase 1b Combination: NUV-868 + EnzalutamideExperimentalNUV-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.
Receives: Drug: NUV-868; Drug: Enzalutamide
Phase 2 Combination: NUV-868 + OlaparibExperimentalNUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.
Receives: Drug: NUV-868; Drug: Olaparib
Phase 2 Combination: NUV-868 + EnzalutamideExperimentalNUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.
Receives: Drug: NUV-868; Drug: Enzalutamide
Phase 2: NUV-868 MonotherapyExperimentalNUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Receives: Drug: NUV-868
Phase 2: Enzalutamide MonotherapyActive comparator160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Receives: Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: During the DLT period (28 days)

  2. 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

    Measured: During the DLT period (28 days)

  3. 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

    Measured: Days 1, 8, and 29

  4. Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD

    Incidence of DLTs

    Measured: During the DLT period (28 days)

  5. 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

    Measured: Days 1, 8, and 57

  6. Phase 2, NUV-868 + Olaparib: Change from Baseline in Tumor Imaging

    ORR per standard criteria

    Measured: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

  7. Phase 2, NUV-868 + Olaparib: Change from Baseline in PSA measurements

    PSA50 response rate per standard criteria; only for patients with prostate cancer

    Measured: Every 4 weeks throughout study treatment, up to an average of 12 months (end of treatment)

  8. 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

    Measured: Every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)

  9. 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

    Measured: 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)

  10. Phase 1b Food Effect Substudy: Effect of Food on the Pharmacokinetics (PK) of NUV-868

    NUV-868 PK parameters in fed and fasted states

    Measured: Pre dose and 24 hours after the first and second doses of NUV-868, 7 days apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start29 Mar 2022
  3. Primary completion15 Jul 2024
  4. Study completion15 Jul 2024

Why it stopped: The Sponsor has achieved its objectives.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential assignment will be applied in Phase 1 and Phase 1 b dose escalation cohorts. Parallel assignment will be applied in Phase 1b backfill cohorts and Phase 2.
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05252390
Sponsor's protocol ID
NUV-868-01
Status last verified
Nov 2025
First submitted
28 Jan 2022
Last updated
6 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NUV-868, Olaparib and Enzalutamide in people with Advanced Solid Tumor and Ovarian Cancer, run by Nuvation Bio Inc. at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor has achieved its objectives.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05252390.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

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