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
Official title: An Open-Label, Multicenter, Dose Escalation And Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: Metastatic Solid Tumors
Locally Advanced Solid Tumors
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs)
timeFrame: 30 days after last dose, approximately 533 days
measure: Tolerability of NKTR-214 as Evaluated by Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: 30 days after last dose, up to 533 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Investigator Site - New Haven
state: Connecticut
city: Portland
country: United States
facility: Investigator Site - Portland
state: Oregon
city: Houston
country: United States
facility: Investigator Site - Houston
state: Texas
Study officials:
References:
citation: 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 IL2Rbetagamma-Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discov. 2019 Jun;9(6):711-721. doi: 10.1158/2159-8290.CD-18-1495. Epub 2019 Apr 15.