Experimental cancer drug INCB062079 tested in early trial
NCT ID NCT03144661
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called INCB062079 in 25 people with advanced liver cancer and other solid tumors. The main goal was to check safety and find the best dose. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INCB062079
- What this could lead to
- If it works, this could point toward a treatment for certain advanced liver and other cancers with specific genetic changes.
- What could go wrong
- This is a very early, small Phase 1 trial that was terminated, so results are limited. The drug may not be effective or safe in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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May 2017
- Finished
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Jun 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Part 1: HCC; cholangiocarcinoma; or esophageal, nasopharyngeal, or serious ovarian cancer, regardless of FGF19/FGFR4 status; or other solid tumor malignancies with documented FGF19/FGFR4 alteration (FGF19/FGFR4 pathway activating alterations include, but are not limited to, FGFR4 amplification, FGFR4 activating mutations, and FGF19 amplification) based on local testing. * Part 2: Subjects will be enrolled into 1 of 3 cohorts: * Cohort A: HCC with FGF19 amplification. * Cohort B: HCC without FGF19 amplification. * Cohort C: cholangiocarcinoma, esophageal, nasopharyngeal or serous ovarian cancers (regardless of FGF19/FGFR4 status), or other solid tumor malignancies with documented FGF19/FGFR4 alteration. * Has progressed after prior therapy and either a) there is no further effective standard anticancer therapy available (including subject refusal) or b) is intolerant to standard anticancer therapy. * Life expectancy \> 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Part 1) or 0-2 (Part 2). * Archival tumor specimen according to protocol-defined criteria. * Centrally analyzed screening C4 (bile acid synthesis precursor) results must be below 40.9 ng/mL, which is the upper limit as determined by the sponsor. * Must agree to take bile acid sequestrants while taking INCB062079. 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; subjects must have recovered from AEs due to previously administered therapies. * Prior receipt of a selective FGFR4 inhibitor within the last 6 months. * Laboratory parameters outside the protocol-defined ranges. * History or presence of an abnormal ECG that in the investigator's opinion is clinically meaningful. * Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non- central nervous system (CNS) disease with medical monitor approval. * History of human immunodeficiency virus infection. * Untreated brain or CNS metastases or brain/CNS metastases that have progressed. Subjects with previously treated and clinically stable brain/CNS metastases and who are off all corticosteroids for ≥ 4 weeks are eligible. * Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment, except concomitant antiviral systemic therapy for chronic hepatitis B or C. * Child-Pugh liver function Class B or C. * History of clinically significant or uncontrolled cardiac disease. * History of allergic reactions to INCB062079, any of the excipients of INCB062079 or similar compounds. * 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 last dose of study drug. * Any medical condition that would in the investigator's judgment interfere with full participation in the study, including administration of study medication and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
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Institut Jules Bordet
Brussels, 1000, Belgium
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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University Hospital (UZ) Leuven
Leuven, 3000, Belgium
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of Toledo Medical Center
Toledo, Ohio, 43614, United States
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