An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

NCT ID: NCT03144661

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-25
• Study Completion Date: 2020-06-10

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC); Cholangiocarcinoma; Esophageal Cancer; Nasopharyngeal Cancer; Ovarian Cancer; Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 - INCB062079 10mg QD

INCB062079 was administered at 10mg once daily

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 1 - INCB062079 10mg BID

NCB062079 was administered at 10mg twice daily

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 1 - INCB062079 15mg BID

NCB062079 was administered at 15mg twice daily

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 1 - INCB062079 10 mg BID + BAS

NCB062079 was administered at 10 mg twice daily in combination with bile acid sequestrants (BAS)

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 1 - INCB062079 15 mg BID + BAS

NCB062079 was administered at 15mg twice daily in combination with bile acid sequestrants (BAS)

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 2 Dose Expansion - Cohort A

HCC Subjects with FGF19 amplification were enrolled to evaluate the dose selected in Part 1

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 2 - Dose Expansion Cohort B

HCC Subjects without FGF19 amplification were enrolled to evaluate the dose selected in Part 1

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Part 2 - Dose Expansion Cohort C

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

Group Type: EXPERIMENTAL

INCB062079

Intervention Type: DRUG

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.

Interventions

INCB062079

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis F. Vinas, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

University of Alabama

Birmingham, Alabama, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Toledo Medical Center

Toledo, Ohio, United States

Institut Jules Bordet

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

University Hospital (UZ) Leuven

Leuven, , Belgium

Countries

United States; Belgium

References

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.

Reference Type: DERIVED

PMID: 36787089 (View on PubMed)

Other Identifiers

2017-001153-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 62079-101

Identifier Type: -

Identifier Source: org_study_id