Vanderbilt Clinical Trials

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

Purpose

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.

Conditions

Advanced Malignancies
Metastatic Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental INCAGN01949		Drug: INCAGN01949 Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.

More Details

Status: Completed
Sponsor: Incyte Biosciences International Sàrl

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.