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Clinical Trial VICCPHI1634

Title

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects with Advanced or Metastatic Solid Tumors

Principal Investigator(s)

Dana Cardin

Details

  • Protocol No. VICCPHI1634
  • Open Date: 08/30/2016
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: International
  • Objective: To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of INCAGN01876 and to define a maximum tolerated dose (MTD) or pharmacologically active dose (PAD) of INCAGN01876 in subjects with advanced or metastatic solid tumors.
  • Disease Sites: Melanoma; Miscellaneous; Kidney (Renal Cell); Lung; Uterine; Non Small Cell
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: INCAGN01876
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02697591
  • Secondary Protocol No: INCAGN 1876-101

Description

Patients are being asked to take part in this research study because they have advanced cancer or metastatic cancer (this means a cancer that cannot be taken out surgically, or that has spread to multiple parts of the body), solid tumors (cancer cells) or certain cancer types. The study is sponsored by Incyte Corporation (the Sponsor) This study has 2 parts; the purpose of Part 1 is to determine what dose of the Study Drug is safe and well tolerated. This part of the Study will also investigate the ways in which this drug is broken down in the body and eliminated, as well as the effects that the drug may have on patient's cancer. During Part 1 of the Study, certain dose levels of The Study Drug will be evaluated in small groups of subjects for a certain period of time before giving a higher dose to the next group of subjects. If certain side effects are observed at a given dose level, additional subjects will be enrolled at the same dose so that these side effects can be studied further. Subjects will be observed for a minimum of 28 days before the dose is increased for the next group of subjects. Enrollment in this part of the Study will continue until the highest dose that is safe and tolerated by most subjects is found. Part 1 subjects will begin receiving the Study Drug every 2 weeks, otherwise known as a treatment cycle. A different treatment cycle (i.e., every 3 weeks or every 4 weeks) may be tested if certain side effects occur. The purpose of Part 2 is to determine if the dose and treatment cycle of the Study Drug chosen from Part 1 is effective for treating specific types of cancer while gathering additional safety data. This part will enroll subjects with certain types of endometrial cancer, melanoma, non-small cell lung cancer, and renal (kidney) cancer.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:All
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
• Part 1: Subjects with advanced or metastatic solid tumors
• Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma
• Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or subjects who refuse standard treatment
• Presence of measureable disease based on RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria:
• Laboratory and medical history parameters not within the protocol-defined range
• Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
• Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy
• Receipt of a live vaccine within 30 days of planned start of study therapy
• Active autoimmune disease that required systemic treatment in the past 2 years