- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02869295
A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors (NKTR-214)
July 9, 2021 updated by: Nektar Therapeutics
An Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06473
- Investigator Site - New Haven
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Oregon
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Portland, Oregon, United States, 97213
- Investigator Site - Portland
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Texas
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Houston, Texas, United States, 77030
- Investigator Site - Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs)
Time Frame: 30 days after last dose, approximately 533 days
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This outcome quantifies the number and types of adverse events associated with NKTR-214.
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30 days after last dose, approximately 533 days
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Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: 30 days after last dose, up to 533 days
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The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.
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30 days after last dose, up to 533 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
October 31, 2018
Study Registration Dates
First Submitted
August 3, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-214-01
- 2016-001134-10 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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