Hepatocellular Carcinoma (HCC)Phase 1NCT03144661
An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
A Phase 1 study testing INCB062079 in people with Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Incyte Corporation at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Esophageal Cancer
- What is being tested?
- INCB062079
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 25 May 2017to 10 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
University of Alabama
Birmingham, Alabama, 35294
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Toledo Medical Center
Toledo, Ohio, 43614
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Cliniques Universitaires Saint-Luc
Brussels, 1200
University Hospital (UZ) Leuven
Leuven, 3000
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
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.
- Conditions
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Esophageal Cancer, Nasopharyngeal Cancer, Ovarian Cancer, Solid Tumors
- Being tested
- INCB062079
- Keywords
- hepatocellular carcinoma, cholangiocarcinoma, esophageal, nasopharyngeal, serous ovarian, solid tumors, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR)
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Esophageal Neoplasms, Nasopharyngeal Neoplasms, Ovarian Neoplasms, Acrocephalosyndactylia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB062079Drug
In Part 1, initial cohort dose of INCB062079 at the protocol-defined starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended dose(s) from Part 1 will be taken forward into Part 2 cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - INCB062079 10mg QD | Experimental | INCB062079 was administered at 10mg once daily Receives: Drug: INCB062079 |
| Part 1 - INCB062079 10mg BID | Experimental | NCB062079 was administered at 10mg twice daily Receives: Drug: INCB062079 |
| Part 1 - INCB062079 15mg BID | Experimental | NCB062079 was administered at 15mg twice daily Receives: Drug: INCB062079 |
| Part 1 - INCB062079 10 mg BID + BAS | Experimental | NCB062079 was administered at 10 mg twice daily in combination with bile acid sequestrants (BAS) Receives: Drug: INCB062079 |
| Part 1 - INCB062079 15 mg BID + BAS | Experimental | NCB062079 was administered at 15mg twice daily in combination with bile acid sequestrants (BAS) Receives: Drug: INCB062079 |
| Part 2 Dose Expansion - Cohort A | Experimental | HCC Subjects with FGF19 amplification were enrolled to evaluate the dose selected in Part 1 Receives: Drug: INCB062079 |
| Part 2 - Dose Expansion Cohort B | Experimental | HCC Subjects without FGF19 amplification were enrolled to evaluate the dose selected in Part 1 Receives: Drug: INCB062079 |
| Part 2 - Dose Expansion Cohort C | Experimental | Subjects with cholangiocarcinoma or esophageal, nasopharyngeal, or serous ovarian cancers (regardless of FGF/FGFR status), or other solid tumor malignancies with documented FGF19/FGFR4 alteration were enrolled to evaluate the dose selected in Part 1 Receives: Drug: INCB062079 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of INCB062079 as measured by assessment of adverse events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
Measured: Baseline to 30-35 days after end of treatment, up to approximately 6 months per subject.
Secondary outcomes (8)
Objective Response Rate
Defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per modified Response Evaluation Criteria (RECIST) in hepatocellular carcinoma (HCC) and standard Response Evaluation Criteria (RECIST v1.1) in participants with other advanced malignancies.
Measured: Every 2 cycles during the treatment period and every 8 weeks during the follow-up period, up to approximately 6 months per subject.
Cmax of INCB062079
Defined as maximum observed plasma concentration.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Tmax of INCB062079
Defined as time to maximum plasma concentration.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cmin of INCB062079
Defined as minimum observed plasma concentration during the dosing interval.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
AUC0-t of INCB062079
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
t½ of INCB062079
Defined as the apparent plasma terminal phase disposition half-life.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cl/F of INCB062079
Defined as oral dose clearance.
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Analysis of biomarkers
A plasma sample will be collected during screening for possible analysis of FGFR4 pathway mutations using tumor circulating DNA.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start25 May 2017
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Why it stopped: Strategic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis F. Vinas, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144661
- Sponsor's protocol ID
- INCB 62079-101
- Other IDs
- 2017-001153-13, 2017
- Status last verified
- Oct 2025
- First submitted
- 5 May 2017
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harding JJ, Jungels C, Machiels JP, Smith DC, Walker C, Ji T, Jiang P, Li X, Asatiani E, Van Cutsem E, Abou-Alfa GK. First-in-Human Study of INCB062079, a Fibroblast Growth Factor Receptor 4 Inhibitor, in Patients with Advanced Solid Tumors. Target Oncol. 2023 Mar;18(2):181-193. doi: 10.1007/s11523-023-00948-8. Epub 2023 Feb 14.
PubMed 36787089
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
- ClinicalTrials.gov ID
- NCT03144661
- Acronym / sponsor ID
- INCB 62079-101
- Conditions
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Esophageal Cancer, Nasopharyngeal Cancer, Ovarian Cancer, Solid Tumors
- Keywords
- hepatocellular carcinoma, cholangiocarcinoma, esophageal, nasopharyngeal, serous ovarian, solid tumors, fibroblast growth factor (FGF), fibroblast growth factor receptor (FGFR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Business Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 - INCB062079 10mg QD | Experimental | Drug: INCB062079INCB062079 was administered at 10mg once daily |
| Part 1 - INCB062079 10mg BID | Experimental | Drug: INCB062079NCB062079 was administered at 10mg twice daily |
| Part 1 - INCB062079 15mg BID | Experimental | Drug: INCB062079NCB062079 was administered at 15mg twice daily |
| Part 1 - INCB062079 10 mg BID + BAS | Experimental | Drug: INCB062079NCB062079 was administered at 10 mg twice daily in combination with bile acid sequestrants (BAS) |
| Part 1 - INCB062079 15 mg BID + BAS | Experimental | Drug: INCB062079NCB062079 was administered at 15mg twice daily in combination with bile acid sequestrants (BAS) |
| Part 2 Dose Expansion - Cohort A | Experimental | Drug: INCB062079HCC Subjects with FGF19 amplification were enrolled to evaluate the dose selected in Part 1 |
| Part 2 - Dose Expansion Cohort B | Experimental | Drug: INCB062079HCC Subjects without FGF19 amplification were enrolled to evaluate the dose selected in Part 1 |
| Part 2 - Dose Expansion Cohort C | Experimental | Drug: INCB062079Subjects with cholangiocarcinoma or esophageal, nasopharyngeal, or serous ovarian cancers (regardless of FGF/FGFR status), or other solid tumor malignancies with documented FGF19/FGFR4 alteration were enrolled to evaluate the dose selected in Part 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB062079In Part 1, initial cohort dose of INCB062079 at the protocol-defined starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended dose(s) from Part 1 will be taken forward into Part 2 cohorts. | Drug | Part 1 - INCB062079 10 mg BID + BAS, Part 1 - INCB062079 10mg BID, Part 1 - INCB062079 10mg QD, Part 1 - INCB062079 15 mg BID + BAS, Part 1 - INCB062079 15mg BID, Part 2 - Dose Expansion Cohort B, Part 2 - Dose Expansion Cohort C, Part 2 Dose Expansion - Cohort A |
Primary outcome
Safety and tolerability of INCB062079 as measured by assessment of adverse events (AEs)
Time frame: Baseline to 30-35 days after end of treatment, up to approximately 6 months per subject.
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
8 secondary outcomes
Objective Response Rate
Time frame: Every 2 cycles during the treatment period and every 8 weeks during the follow-up period, up to approximately 6 months per subject.
Cmax of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Tmax of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cmin of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
AUC0-t of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
t½ of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Cl/F of INCB062079
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment, up to approximately 2 months per subject.
Analysis of biomarkers
Time frame: Screening visit
Results and safety
The study was stopped early (reason given: Strategic Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Derived from this study: PubMed 36787089Harding JJ, Jungels C, Machiels JP, Smith DC, Walker C, Ji T, Jiang P, Li X, Asatiani E, Van Cutsem E, Abou-Alfa GK. First-in-Human Study of INCB062079, a Fibroblast Growth Factor Receptor 4 Inhibitor, in Patients with Advanced Solid Tumors. Target Oncol. 2023 Mar;18(2):181-193. doi: 10.1007/s11523-023-00948-8. Epub 2023 Feb 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F. Vinas, MD study director
Incyte Corporation
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB062079 in people with Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Incyte Corporation at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of INCB062079 as measured by assessment of adverse events (AEs) (time frame: Baseline to 30-35 days after end of treatment, up to approximately 6 months per subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.