A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Incyte Biosciences International Sàrl8 sites in 4 countries87 target enrollmentOctober 31, 2016

ConditionsAdvanced Malignancies Metastatic Cancer

InterventionsINCAGN01949

DrugsINCAGN01949

Overview

Phase: Phase 1
Intervention: INCAGN01949
Conditions: Advanced Malignancies
Sponsor: Incyte Biosciences International Sàrl
Enrollment: 87
Locations: 8
Primary Endpoint: Number of Participants With Treatment-related Adverse Events
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.

Registry

clinicaltrials.gov

Start Date

October 31, 2016

End Date

March 26, 2019

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Incyte Biosciences International Sàrl

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
•Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
•Part 1: Subjects with advanced or metastatic solid tumors.
•Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
•Presence of measureable disease based on RECIST v1.
•Eastern Cooperative Oncology Group performance status 0 or 1.

Exclusion Criteria

•Laboratory and medical history parameters not within the protocol-defined range.
•Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
•Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
•Receipt of a live vaccine within 30 days of planned start of study drug.
•Active autoimmune disease that required systemic treatment in the past.

Arms & Interventions

INCAGN01949

Intervention: INCAGN01949

Outcomes

Primary Outcomes

Number of Participants With Treatment-related Adverse Events

Time Frame: From screening through 60 days after end of treatment, up to 11 months

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Secondary Outcomes

Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
Objective Response Rate Per RECIST and Modified RECIST(Baseline and every 8 weeks,up to 11 months)
Duration of Response Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
Progression-free Survival Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
Duration of Disease Control Per RECIST and Modified RECIST(Baseline and every 8 weeks, up to 11 months)
Time to Maximum Concentration of INCAGN01949 in Plasma(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)
Summary of Trough Concentrations(Cmin) of INCAGN01949(Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6)