A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors

NCT02869295 | Completed Phase 1 Results

• 2 other identifiers: 15-214-012016-001134-10
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

Metastatic Solid Tumors; Locally Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs)

  This outcome quantifies the number and types of adverse events associated with NKTR-214.

  30 days after last dose, approximately 533 days

• Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs)

  The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.

  30 days after last dose, up to 533 days

Study Arms (1)

NKTR-214 Dose Escalation

EXPERIMENTAL

This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR--214 in adult patients with locally advanced and metastatic solid tumors. The Phase 1 stage of the study is designed as an open-label dose escalation trial of NKTR--214 in participants with locally advanced or metastatic solid tumors. The goal of the dose escalation stage of the study is to find the recommended phase 2 dose, to evaluate the efficacy of NKTR--214 by assessing the objective response rate and to evaluate the safety of NKTR-214. Immunological biomarkers in plasma and tumor samples will also be measured.

Drug: NKTR-214

Interventions

NKTR-214 DRUG

Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.

NKTR-214 Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor.
• Received 1 or 2 prior lines of therapy.
• Life expectancy \>12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Measurable disease per RECIST v1.1.
• Demonstrated adequate organ function within 14 days of treatment initiation.
• Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy or surgery.
• Women of childbearing potential must agree to use highly effective methods of birth control.
• All participants must agree to use double barrier contraception during study participation and for at least 2 months after the last dose of study drug.
• Additional criteria may apply.

You may not qualify if:

• Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR-214.
• Females who are pregnant or breastfeeding.
• Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
• Active central nervous system (CNS) metastases.
• Prior surgery or radiotherapy within 14 days of therapy.
• Participants who have had \< 28 days since the last chemotherapy, immunotherapy, biological therapy, or \< 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.
• Participants' inability to adhere to or tolerate protocol or study procedures.
• Additional criteria may apply.

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (3)

Investigator Site - New Haven

New Haven, Connecticut, 06473, United States

Location

Investigator Site - Portland

Portland, Oregon, 97213, United States

Location

Investigator Site - Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Bentebibel SE, Hurwitz ME, Bernatchez C, Haymaker C, Hudgens CW, Kluger HM, Tetzlaff MT, Tagliaferri MA, Zalevsky J, Hoch U, Fanton C, Aung S, Hwu P, Curti BD, Tannir NM, Sznol M, Diab A. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rbetagamma-Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discov. 2019 Jun;9(6):711-721. doi: 10.1158/2159-8290.CD-18-1495. Epub 2019 Apr 15.

  PMID: 30988166 RESULT

Related Links

• This article outlines the significance of the trial as well as the results

MeSH Terms

Interventions

bempegaldesleukin

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

medicalaffairs@nektar.com

415-482-5300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 16, 2016
• Study Start: December 1, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: July 29, 2021
• Results First Posted: July 29, 2021

Record last verified: 2021-07

Locations

US (3)