Status:
TERMINATED
NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Nuvation Bio Inc.
Conditions:
Advanced Solid Tumor
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tumo...
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.
Eligibility Criteria
Inclusion
- Key Inclusion Criteria For All Phases and Cohorts:
- 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
- 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
- Key Exclusion Criteria For All Phases and Cohorts:
- 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.
Exclusion
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05252390
Start Date
March 29 2022
End Date
July 15 2024
Last Update
November 6 2025
Active Locations (22)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Ellison Institute of Technology
Los Angeles, California, United States, 90064
3
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
4
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124