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

Phase 1

Completed

• Conditions: Advanced Malignancies; Metastatic Cancer
• Interventions: Drug: INCAGN01949

• Registration Number: NCT02923349
• Lead Sponsor: Incyte Biosciences International Sàrl

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Study Start: 2016-10-31
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Results First Submitted: 2020-03-26
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Results First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 v1.1.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INCAGN01949	INCAGN01949	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Adverse Events	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 Outcome Measures

Name	Time	Method
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	To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
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	To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Objective Response Rate Per RECIST and Modified RECIST	Baseline and every 8 weeks,up to 11 months	ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Duration of Response Per RECIST and Modified RECIST	Baseline and every 8 weeks, up to 11 months	ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Progression-free Survival Per RECIST and Modified RECIST	Baseline and every 8 weeks, up to 11 months	ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Duration of Disease Control Per RECIST and Modified RECIST	Baseline and every 8 weeks, up to 11 months	ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
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	To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
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	To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949

Trial Locations

Locations (8)

Rutgers, The State University of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University Hospital of Laussane (CHUV); 🇨🇭 Lausanne, Switzerland

University of Oxford; 🇬🇧 Oxford, United Kingdom

Vall d'Hebron Institute of Oncology (VHIO); 🇪🇸 Barcelona, Spain

New York University Clinical Cancer Center; 🇺🇸 New York, New York, United States

University College Hospital; 🇬🇧 London, United Kingdom

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States