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NKTR-214

Phase 1

Unspecified Adult Solid Tumor, Protocol Specific | Small molecule | Oncology |Nektar Therapeutics|Last Updated: Jul 29, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

NKTR-214 · 1 trial · 1 indication

Phase 1 1
NCT02869295A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid TumorsUnspecified Adult Solid Tumor, Protocol Specific
COMPLETED28 Analytics
PHASE1COMPLETED
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 SpecificUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of NKTR-214 as Evaluated by Incidence of Drug-related Adverse Events (AEs)
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)
30 days after last dose, up to 533 days

The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NKTR-214 Dose EscalationEXPERIMENTALThis 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.

Interventions

NameTypeDescription
NKTR-214DRUGParticipants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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. * Demonstrat...

Countries:United States
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Frequently asked questions about NKTR-214

What is NKTR-214 used for?

NKTR-214 is an investigational small molecule being studied for the treatment of unspecified adult solid tumors, as defined by the specific protocol. It is in Phase 1 clinical development for oncology indications.

Who makes NKTR-214?

NKTR-214 is being developed by Nektar Therapeutics, a biopharmaceutical company. The company's ticker symbol is NKTR.

What phase is NKTR-214 in?

NKTR-214 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is NKTR-214 in?

NKTR-214 has been studied in a Phase 1/2 multicenter dose escalation and expansion trial (NCT02869295) in subjects with locally advanced or metastatic solid tumors. This trial, conducted in the United States, enrolled 28 participants and has been completed.

Is NKTR-214 the same as bempegaldesleukin?

NKTR-214 is also known as bempegaldesleukin. It is an investigational small molecule being developed by Nektar Therapeutics for the treatment of solid tumors.