A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors (NKTR-214)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02869295|
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : July 29, 2021
Last Update Posted : July 29, 2021
|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.
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|