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

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ClinicalTrials.gov Identifier: NCT02869295
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : July 29, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: NKTR-214 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
Actual Study Start Date : December 2015
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs) [ Time Frame: 30 days after last dose, approximately 533 days ]
    This outcome quantifies the number and types of adverse events associated with NKTR-214.

  2. Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 30 days after last dose, up to 533 days ]
    The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869295


Locations
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United States, Connecticut
Investigator Site - New Haven
New Haven, Connecticut, United States, 06473
United States, Oregon
Investigator Site - Portland
Portland, Oregon, United States, 97213
United States, Texas
Investigator Site - Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Nektar Therapeutics
  Study Documents (Full-Text)

Documents provided by Nektar Therapeutics:
Study Protocol  [PDF] October 24, 2016
Statistical Analysis Plan  [PDF] February 2, 2018

Additional Information:
Publications of Results:
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Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT02869295    
Other Study ID Numbers: 15-214-01
2016-001134-10 ( EudraCT Number )
First Posted: August 16, 2016    Key Record Dates
Results First Posted: July 29, 2021
Last Update Posted: July 29, 2021
Last Verified: July 2021
Keywords provided by Nektar Therapeutics:
Metastatic Solid Tumors
Locally Advanced Solid Tumors
Additional relevant MeSH terms:
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Neoplasms