MedDataX Logo

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

NCT ID: NCT05252390

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2024-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor Ovarian Cancer Ovary Cancer Cancer of Ovary Cancer of the Ovary Ovary Neoplasm Pancreatic Cancer Pancreas Cancer Cancer of Pancreas Cancer of the Pancreas Pancreas Neoplasm Prostate Cancer Prostatic Cancer Cancer of Prostate Cancer of the Prostate Prostate Neoplasm Castrate Resistant Prostate Cancer Castration Resistant Prostatic Cancer Castration Resistant Prostatic Neoplasms Triple-negative Breast Cancer Triple Negative Breast Cancer Triple Negative Breast Neoplasms Breast Cancer Breast Carcinoma Cancer of Breast Cancer of the Breast Breast Tumor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

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.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

Olaparib

Intervention Type DRUG

Olaparib

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.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

Enzalutamide

Intervention Type DRUG

Enzalutamide

Phase 2 Combination: NUV-868 + Olaparib

NUV-868 will be administered at the RP2cD.

Olaparib will be administered at the RP2cD.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

Olaparib

Intervention Type DRUG

Olaparib

Phase 2 Combination: NUV-868 + Enzalutamide

NUV-868 will be administered at the RP2cD.

Enzalutamide will be administered at the RP2cD.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

Enzalutamide

Intervention Type DRUG

Enzalutamide

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.

Group Type EXPERIMENTAL

NUV-868

Intervention Type DRUG

NUV-868 is an investigational drug for oral dosing.

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.

Group Type ACTIVE_COMPARATOR

Enzalutamide

Intervention Type DRUG

Enzalutamide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NUV-868

NUV-868 is an investigational drug for oral dosing.

Intervention Type DRUG

Olaparib

Olaparib

Intervention Type DRUG

Enzalutamide

Enzalutamide

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lynparza Xtandi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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


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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nuvation Bio Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Ellison Institute of Technology

Los Angeles, California, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Laura & Isaac Perlmutter Cancer Center - NYU Langone Health

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, United States

Site Status

NEXT Virginia

Fairfax, Virginia, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Macquarie University Hospital

North Ryde, New South Wales, Australia

Site Status

Calvary Mater Hospital Newcastle

Waratah, New South Wales, Australia

Site Status

Cabrini Hospital Malvern

Malvern, Victoria, Australia

Site Status

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Linear Clinical Research

Nedlands, Western Australia, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NUV-868-01

Identifier Type: -

Identifier Source: org_study_id