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Hepatocellular CarcinomaPhase 1HCCNCT06337162

Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC)

A Phase 1 study testing INCB099280 in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
INCB099280
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2024to 1 Sep 2028
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

  • Must have hepatocellular carcinoma (HCC) that is within criteria for liver transplantation per review at multidisciplinary tumor board. This includes HCC tumors meeting downstaging criteria, per United Network for Organ Sharing (UNOS) guidelines.
  • Age > 18 years and ability to understand and the willingness to sign a written informed consent document.
  • No prior systemic therapies for HCC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Child-Pugh cirrhosis score of A5, A6, or B7
  • Must be willing to comply with protocol procedures.
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  • Patients who are undergoing locoregional therapies must have resolution of clinical (i.e. not laboratory) adverse effects associated with the locoregional therapy to grade ≤1 or baseline (whichever is higher).
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days of the first dose of INCB099280.
  • Must have adequate organ and hematopoietic function within 7 days of initiation of study therapy (including Cycle 1 Day 1 labs if needed).

Who cannot join

  • Any history of a serious medical or psychiatric condition that would prevent the subject from signing the informed consent form.
  • Intercurrent illness that might interfere with compliance or study completion.
  • Pregnant, expecting to conceive, or breastfeeding starting with the screening visit through 190 days after the last dose of study treatment or expecting to father children starting with the screening visit through 100 days after the last dose of study treatment.
  • Subjects may not receive concomitant anticancer agents (except protocol specified INCB099280). Long-term hormonal agents used in the adjuvant setting for other cancers (e.g. tamoxifen for breast cancer, leuprolide for prostate cancer) are permitted.
  • Uncontrolled ascites (i.e. requiring paracentesis).
  • Hepatic encephalopathy symptoms within 6 months prior to starting study therapy.
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  • Portal vein invasion or extrahepatic metastatic disease.
  • Treatment with non-steroidal systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment. Systemic agents for skin-only conditions such as atopic dermatitis or psoriasis may be permissible at the discretion of the Principal Investigator.
  • Any concurrent condition requiring the continued or anticipated use of systemic steroids beyond physiologic replacement dosing (excluding non-systemic inhaled, topical skin, nasal, and/or ophthalmic corticosteroids). All other systemic corticosteroids above physiologic replacement dosing must be discontinued at least 2 weeks prior to first study treatment. Patients who receive a corticosteroid pulse for IV contrast allergies are eligible.
  • Active drug or alcohol use or dependence as documented in the chart that, in the opinion of the investigator, would interfere with adherence to study requirements or interfere with eligibility for liver transplantation.
  • Serious active bacterial or fungal infection requiring oral or intravenous antibiotics or antifungals at the start of protocol treatment. Participants may enroll after a 28-day washout period. Prophylactic or suppressive antibiotics (e.g. for spontaneous bacterial peritonitis prophylaxis, dental procedures, or surgical prophylaxis) are allowed.
  • A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results and/or eligibility for liver transplantation. Exceptions may be made if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy and the participant is otherwise a candidate for Liver Transplant (Note: The time requirement for no evidence of disease for 3 years does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, other noninvasive or indolent malignancies, or other in situ cancers if the presence or history of these cancers would not otherwise affect candidacy for liver transplant (LT)).
  • Prior organ allograft or allogeneic bone marrow transplantation.
  • Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, psoriasis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions with low risk of complications due to Immune Checkpoint Inhibitors (ICI) use may be allowable at the discretion of the Principal Investigator.
  • Any other conditions judged by the investigator that would limit the evaluation of the subject.
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • If Hepatitis B surface antigen positive, must be on hepatitis B antiviral therapy for at least 21 days prior to starting study therapy and continue antiviral therapy for at least one year following cessation of study therapy.
  • Impaired cardiac function or clinically significant cardiac disease: New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy, unstable angina pectoris, acute myocardial infarction ≤ 6 months before study participation, other clinically significant heart disease (ie, uncontrolled ≥ Grade 3 hypertension), and/or Clinically significant ECG abnormality, including Corrected QT Interval Using Fridericia's Formula (QTcF) interval > 480 milliseconds (Note: If a single ECG tracing at screening is > 480 milliseconds, the average of a triplicate ECG may be used).
  • History or evidence of interstitial lung disease, including noninfectious pneumonitis.
  • Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit, including gastric bypass surgery, gastric sleeve, or gastric band.
  • Diagnosis of primary immunodeficiency.
  • HIV infection and any one or more of the following: Cluster of Differentiation 4 (CD4) + T-cell count < 200 cells/μL, detectable viral load, or antiretroviral therapy regimen containing moderate or potent CYP3A4/CYP3A5 inhibitors or inducers (Note: Participants modifying their HIV regimen to include only drugs without CYP3A4/5 inhibitors or inducers must be on a stable regimen for > 28 days prior to enrollment)
  • Known hypersensitivity or severe reaction to any component of study drug or formulation components.
  • Postoperative complications preventing the participant from adhering to protocol assessments and procedures.
  • Received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox, some shingles, yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.
  • Treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers Note: A washout period ≥ 10 days before the first dose of INCB099280 is required for prior treatment with CYP3A4/CYP3A5 inhibitors/inducers.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center at University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Pilot Study of Neoadjuvant INCB099280 in Patients With Hepatocellular Carcinoma Awaiting Liver Transplant

This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant.

Being tested
INCB099280
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB099280Drug

    400 mg Tablet

Study groups in NCT06337162
Study groupRoleWhat they receive
INCB099280ExperimentalStudy participants will receive the recommended phase II dose (400mg/kg) of INCB099280 orally on days 1 through 28 of each 28-day cycle until liver transplant.
Receives: Drug: INCB099280

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy

    Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 1 month of liver transplantation that is at least possibly related to study therapy

    Measured: From liver transplant until 1 month after liver transplant

Secondary outcomes (7)

  1. Acute Cellular Rejection of Liver Transplant Within 3 Months

    Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 3 month of liver transplantation

    Measured: From liver transplant until 3 months after liver transplant

  2. Acute Cellular Rejection of Liver Transplant Within 1 Year

    Proportion of patients who undergo liver transplant who experience biopsy-proven acute cellular rejection of liver transplant using Banff Criteria within 1 year of liver transplantation

    Measured: From liver transplant until 1 year after liver transplant

  3. Toxicity Rates by Category and Grade

    Treatment-emergent adverse events graded using CTCAE v. 5.0

    Measured: From start of study therapy to 1 month after liver transplant

  4. Proportion of Patients Downstaged

    Proportion of patients outside of the Milan Criteria at study entry who undergo liver transplant

    Measured: From start of study therapy to liver transplant, an average of 6 months

  5. Pathologic Complete Response Rate

    Proportion of patients undergoing liver transplant with a complete pathologic response on liver explant

    Measured: At time of liver transplant, an average of 6 months

  6. Recurrence-Free Survival at 1 Year After Transplant

    Proportion of patients who undergo liver transplant without recurrence of hepatocellular carcinoma within 1 year after transplant

    Measured: From liver transplant until 1 year after liver transplant

  7. Overall Survival at 1 Year After Transplant

    Proportion of patients who undergo liver transplant who are alive 1 year after transplant

    Measured: From liver transplant until 1 year after liver transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Why it stopped: Incyte made a strategic business decision to stop enrollment to all ongoing oral PD-L1 (99280) studies. This decision was made based on an internal review and reprioritization of the existing pipeline.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337162
Sponsor's protocol ID
UPCC 20223
Other IDs
IRB#855195
Acronym
HCC
Status last verified
Aug 2024
First submitted
18 Mar 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB099280 in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

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 9 inclusion and 26 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: withdrawn, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 withdrawn before enrolling participants, so there are no results.

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?

Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy (time frame: From liver transplant until 1 month after liver transplant). 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 NCT06337162.

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 9 Aug 2024.

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