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)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
- 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
Contact Us
(410) 955-8964Brief Summary
Experimental: Phase 1 Monotherapy Dose Escalation NUV-868 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.
Experimental: Phase 1b Dose Escalation: 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 Dose Escalation: 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.
Eligibility
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.