Dose Escalation Study of NKP-1339 to Treat Advanced Solid Tumors

Niiki Pharma Inc.46 enrolled

Overview

The purpose of this study is to determine the safety and maximal tolerated dose of NKP-1339, a ruthenium containing compound administered intravenously on a weekly schedule, in patients with advanced solid tumors. The responses to treatment in this population will be evaluated. In addition, the PD and PK properties of the compound will be explored.

NKP-1339 is a novel GRP78 targeted ruthenium based anti-cancer compound which is intravenously administered. GRP78 is a key regulator of misfolded protein processing, which is unregulated in cancer cells. In nonclinical anti-tumor studies, NKP-1339 showed activity against many tumor types, including those resistant to platinum and other standard anti-cancer agents. This Phase I trial evaluates the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of NKP-1339.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

NKP-1339DRUG

NKP-1339 is administered as a 30-90 minute IV infusion (based on volume to be infused) on days 1, 8, and 15 of a 28 day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥ 18 years with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies who have signed an IRB approved Informed Consent Form (ICF). * ECOG PS 0 or 1. * Adequate hematologic, hepatic and renal function * Minimum life expectancy ≥ 12 weeks Exclusion Criteria: * No supplemental Iron, i.e., therapeutic or as part of a multivitamin regimen. * No chemotherapy, immunotherapy, or radiotherapy for \< 4 weeks, BMTs \< 9 months or major surgery \< 3 weeks. * No symptomatic central nervous system metastases. No primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing dose of steroids. * No evidence of ischemia, MI within the past 6 months, or other significant abnormality on ECG. * No clinically significant active infection including HIV, hepatitis B, or hepatitis C. * No Peripheral neuropathy ≥ Grade 2

Locations (2)

TGEN Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, United States

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of participants with related adverse events

The incidence and severity of related adverse events and laboratory abnormalities will be used to assess the safety and tolerability of NKP-1339.

Time frame: 8 weeks

Secondary Outcomes

Composite of pharmacokinetics

Plasma and urine samples will be analyzed to determine Cmax, Tmax, AUC, terminal elimination rate, elimination half-life, clearance,and volume of distribution.

Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 10 and 24 hours

To report any responses to NKP-1339 in subjects with advanced tumors

Tumor assessments every 2 cycles if patients continue treatment beyond 2 Cycles. Treatment is allowed beyond 2 cycles in patients who achieved at least stable disease, at the discretion of investigator and consent of the patient.

Time frame: >8 weeks

To explore pharmacodynamic endpoints which may be of use in the further development of NKP-1339

Transferrin, transferrin receptor and GRP-78 in plasma.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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