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Completed

NCT Number: NCT01415297

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

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TGEN Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NKP-1339

Drug

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.

Other names: IT-139

Primary outcomes

  1. Number of participants with related adverse events

    Time frame: 8 weeks

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

Secondary outcomes

  1. Composite of pharmacokinetics

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

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

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

    Time frame: >8 weeks

    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.

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

    Time frame: 8 weeks

    Transferrin, transferrin receptor and GRP-78 in plasma.

Sponsors and collaborators

Lead sponsor

Niiki Pharma Inc.

Industry

Registry information

Official study title

A Phase I Dose Escalation Study of NKP-1339 Administered on Days 1, 8 and 15 of Each 28-Day Cycle in Patients With Advanced Solid Tumors Refractory to Treatment

Important dates

Study start
2009
Primary completion
2012
Study completion
2016
First posted
Aug 11, 2011
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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