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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NUV-868 — DRUG
  NUV-868 is an investigational drug for oral dosing.
• Olaparib — DRUG
  Olaparib
• Enzalutamide — DRUG
  Enzalutamide

Study Details

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.

Key Dates

Start date

Mar 29, 2022

Status verified

Nov 2025

Primary completion

Jul 15, 2024

Completion

Jul 15, 2024

Study Design

Enrollment

82 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.
• Experimental: Phase 2 Combination: NUV-868 + Olaparib
  NUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.
• Experimental: Phase 2 Combination: NUV-868 + Enzalutamide
  NUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.
• 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.
• 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.

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) ]

Locations (17)

Find similar trials in Tucson, AZ

Related Studies

• Collection of Blood From Patients With Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Harvesting Cells for Experimental Cancer Treatments
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland