A Phase 1, Open-Label, Dose-Escalation Study of NEV801, Administered to Patients With Advanced Cancers

NCT02797795 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NEV801-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a first-in-human, multicenter, open-label, nonrandomized, dose-escalation trial to be conducted in 2 sequential parts:

• Part A (Dose Escalation) in subjects with advanced malignancies
• Part B (Dose Confirmation) in subjects with tumor type(s) to be determined by results of Part A

Conditions

Advanced Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  12 months

Secondary Outcomes (1)

• Observe any antitumor effects of NEV801

  24 months

Study Arms (1)

NEV801

EXPERIMENTAL

Part A - Dose escalation and de-escalation for the determination of the Maximum tolerated dose. All subjects will receive NEV801 intravenously on days 1, 8, 15 and 22 during each 28-day cycle. Part B - Subjects will receive NEV801 at or below the highest tolerable dose from Part A.

Drug: NEV801

Interventions

NEV801 DRUG

Dose Escalation

NEV801

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age
• Willing and able to provide written informed consent and comply with the requirements of the study
• Pathologically confirmed advanced malignancy for which standard therapy proven to provide clinical benefit does not exist or is no longer effective
• Part A only: Evaluable disease, measurable either on physical examination or by imaging according to RECIST v1.1 or by informative tumor marker(s)
• Part B only: Selected tumor type(s), as determined by results of Part A
• Part B only: Measurable disease, using RECIST v1.1
• ECOG performance status of 0 or 1

You may not qualify if:

• Receipt of more than 5 prior regimens of cytotoxic chemotherapy (unless prior approval is granted by the Sponsor)
• Any chemotherapy, immunomodulatory drug therapy, antineoplastic hormonal therapy, immunosuppressive therapy, corticosteroids \> 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (e.g., erythropoietin) within 14 days before first NEV801 dose
• Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ≤ Grade 1, according to the NCI CTCAE v4.03
• Radiotherapy within 28 days before the first NEV801 dose
• Use within 7 days of the first NEV801 dose, or anticipated use, of agents that are strong inhibitors of CYP3A4, CYP1A2 and CYP2D6 enzymes (unless approved by the Sponsor) - see Section 5.6 for a list of strong CYP3A4, CYP1A2 and CYP2D6 inhibitors
• Use of any investigational agents within 28 days of the first NEV801 dose
• Major surgery within 28 days before the first NEV801 dose
• Life expectancy \< 12 weeks
• Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months before the first NEV801 dose
• History of or ongoing cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QT corrected by the Fridericia formula (QTcF) interval to \> 450 msec for males or \> 470 msec for females
• Previous malignancy other than non-squamous-cell carcinoma of skin or carcinoma in situ of the uterine cervix (unless the tumor was treated with curative intent more than 2 years before the first NEV801 dose)
• Active bacterial, viral, or fungal infection requiring systemic therapy.
• Known HIV infection or AIDS-related illness
• Known active viral hepatitis
• Presence of genetic polymorphism of UGT1A1 leading to reduced glucuronidation

Sponsors & Collaborators

• Neovia Oncology Ltd.: lead

Study Sites (2)

Research Facility

Boston, Massachusetts, 02215, United States

Location

Research Facility

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)