Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02869295 | A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors | PHASE1 | COMPLETED | 28 | — | — | Dec 1, 2015 | Oct 31, 2018 | Jul 29, 2021 | 3 | United States |
This outcome quantifies the number and types of adverse events associated with NKTR-214.
The data below reflects the incidence of Dose Limiting Toxicity Events observed in this trial.
| Arm | Type | Description |
|---|---|---|
| NKTR-214 Dose Escalation | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| NKTR-214 | DRUG | Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression. |
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...