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Trial record 1 of 2 for:    NKTR-214
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A Phase 1 Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors (NKTR-214)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT02869295
First received: August 3, 2016
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: NKTR-214
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Safety of NKTR-214 as evaluated by incidence of drug-related adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 30 days after last dose ]
  • Tolerability of NKTR-214 as evaluated by incidence of dose limiting toxicities (DLTs), drug-related adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 30 days after last dose ]

Secondary Outcome Measures:
  • Objective response rate (ORR) of NKTR-214 based on investigator review of radiographic images [ Time Frame: Through study completion, an expected average of 1 year ]
  • Best overall response (BOR) in the population of interest [ Time Frame: Through study completion, an expected average of 1 year ]
  • Duration of Response (DOR) [ Time Frame: Through study completion, an expected average of 1 year ]
    It is defined as time between the date of first radiographic documented objective response and the date of the radiographic documented disease progression.

  • Progression-Free Survival (PFS) [ Time Frame: Through study completion, an expected average of 1 year ]
    PFS is defined as the time from date of enrollment to the date of the first objectively documented tumor progression or death due to any cause

  • Clinical benefit rate (CBR) [ Time Frame: Through study completion, an expected average of 1 year ]
    Clinical benefit rate will be assessed as the number of subjects with confirmed complete response (CR), partial response (PR), or stable disease (SD) (where the duration of SD should be ≥ 3 months) divided by the total number of subjects in the Response Evaluable Population

  • Median time to response (MTR) [ Time Frame: Through study completion, an expected average of 1 year ]
    The median time to response will be summarized descriptively for subjects who have a CR or PR.

  • Overall Survival (OS) [ Time Frame: Within 3 years from study start ]
    Overall survival is defined as the time from date of enrollment to the date of death.

  • Maximum observed plasma concentration (Cmax) of NKTR-214 [ Time Frame: Day 1 of Cycle 1 and 2: pre-dose and end of administration, 0.5 hr., 3 hr., 6 hr., Post dosing on Days 2, 3, 4, 5, 8, 11, and 15 for Cycle 1 and 2 ]
  • Time of maximum observed plasma concentration (Tmax) of NKTR-214 [ Time Frame: Day 1 of Cycle 1 and 2: pre-dose and end of administration, 0.5 hr., 3 hr., 6 hr., Post dosing on Days 2, 3, 4, 5, 8, 11, and 15 for Cycle 1 and 2 ]
  • Area under the plasma concentration time curve in the dosing interval AUC(TAU) of NKTR-214 [ Time Frame: Day 1 of Cycle 1 and 2: pre-dose and end of administration, 0.5 hr., 3 hr., 6 hr., Post dosing on Days 2, 3, 4, 5, 8, 11, and 15 for Cycle 1 and 2 ]
  • Half life (t½) of NKTR-214 [ Time Frame: Day 1 of Cycle 1 and 2: pre-dose and end of administration, 0.5 hr., 3 hr., 6 hr., Post dosing on Days 2, 3, 4, 5, 8, 11, and 15 for Cycle 1 and 2 ]
  • Functional and phenotypic characterization of peripheral immune cells by flow cytometry [ Time Frame: Day 1 and Day 8 of Cycle 1 and 2 ]
  • Changes in soluble cytokines and chemokines by multiplex immunoassay [ Time Frame: Day 1 and Day 8 of Cycle 1 and 2 ]
  • Functional and phenotypic characterization of tumor immune infiltrates (TIL) by flow cytometry. [ Time Frame: Pre-dose and week 3 after first dose ]
  • Functional and phenotypic characterization of tumor immune infiltrate (TIL) by next generation sequencing of T cell receptors [ Time Frame: Pre-dose and week 3 after first dose ]
  • Functional and phenotypic characterization of tumor immune infiltrate (TIL) by immunohistochemistry (IHC) [ Time Frame: Pre-dose and week 3 after first dose ]
  • Immunogenicity analysis to assess antibodies to NKTR-214 in human serum [ Time Frame: Screening and pre-dose of Day 1 of Cycle 2 and odd-numbered cycles there after (Cycle 3, 5, 7…) ]

Estimated Enrollment: 40
Actual Study Start Date: December 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-214 Dose Escalation
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
Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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, cobretinib), 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02869295

Contacts
Contact: Nektar Recruitment 855-482-8676 StudyInquiry@nektar.com

Locations
United States, Connecticut
Yale Medical Center Active, not recruiting
New Haven, Connecticut, United States, 06473
United States, Oregon
Providence Cancer Center Active, not recruiting
Portland, Oregon, United States, 97213
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nektar Therapeutics
  More Information

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT02869295     History of Changes
Other Study ID Numbers: 15-214-01
2016-001134-10 ( EudraCT Number )
Study First Received: August 3, 2016
Last Updated: March 27, 2017

Keywords provided by Nektar Therapeutics:
Metastatic Solid Tumors
Locally Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 24, 2017