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
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|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: NKTR-214||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
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.
Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
- 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.
- 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.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
Documents provided by Nektar Therapeutics:
Publications of Results:
|Responsible Party:||Nektar Therapeutics|
|Other Study ID Numbers:||
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|
Metastatic Solid Tumors
Locally Advanced Solid Tumors