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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— NKTR-214  

Official title:

An Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869295
• Other study ID #: 15-214-01
• Secondary ID: 2016-001134-10
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: July 2021
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• NKTR-214
Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.

Locations

Country	Name	City	State
United States	Investigator Site - Houston	Houston	Texas
United States	Investigator Site - New Haven	New Haven	Connecticut
United States	Investigator Site - Portland	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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