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

Niiki Pharma

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: NKP-1339

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415297

NKP-1339-09-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

NKP-1339

Experimental group

Description:

NKP-1339 will be administered in single patient cohorts until ≥ Grade 2 toxicity encountered, at which time cohorts converted to a standard 3 + 3 dose escalation scheme. When MTD is reached, an expanded cohort of up to 25 patients will be enrolled at the MTD.

Treatment:

Drug: NKP-1339