A Phase 1 Open-Label Dose-Escalation and Expansion Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

S
Safi Shahda, MD

Primary Investigator

Overview

The purpose of this study is to evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.

Description

The purpose of this study is to test different doses of INCB062079 and see which doses are safe and tolerable in subjects that have hepatocellular carcinoma and other solid tumor malignancies and to select the doses that will be studied further.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    hepatocellular carcinoma
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
Hepatocellular carcinoma (HCC); cholangiocarcinoma; or esophageal, nasopharyngeal, or serous ovarian cancers
Has progressed after prior therapy and either a) there is no further effective standard anticancer therapy available (including subject refusal) or b) subject is intolerant to standard anticancer therapy
Life expectancy > 12 weeks
Willingness to avoid pregnancy or fathering children
Exclusion Criteria
Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 28 days before first dose of study drug
Prior radiotherapy within 2 weeks of study treatment
History of human immunodeficiency virus infection
Untreated brain or CNS metastases or brain/CNS metastases that have progressed
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment, except concomitant antiviral systemic therapy for chronic hepatitis B or C
History of clinically significant or uncontrolled cardiac disease
Pregnant or nursing women or subjects expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study drug
Concurrent anticancer therapy
Known additional malignancy that is progressing or requires active treatment


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022. Study ID: 1706925482 (INCB62079-101)

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