Study of INCB086550 in Select Solid Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 2 Study of INCB086550 (Oral PD-L1 Inhibitor) in Participants Who Are Immune Checkpoint Inhibitor-Naïve With Selected Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04629339
• Other study ID #: INCB 86550-203
• Status: Terminated
• Phase: Phase 2
• Start date: September 2, 2021
• Est. completion date: March 26, 2024

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to comprehend and willingness to sign a written ICF for the study.

• Participants with following tumor types : non small cell lung cancer, renal cell carcinoma, urothelial carcinoma, hepatocellular carcinoma and melanoma

• Measurable disease per RECIST v1.1.

• ECOG performance status of 0 to 1 for all tumor types. Urothelial carcinoma allows ECOG of 0 to 2.

• Histologically or cytologically confirmed disease-specific diagnosis as per protocol.

• Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

• Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL2, 4-1BB, CAR-T).

• Receipt of any anticancer therapy or participation in another interventional clinical study.

• Radiotherapy within 14 days of first dose of study treatment.

• Concomitant treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers.

• Toxicity of prior therapy that has not recovered to = Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with the medical monitor.

• Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.

• Participants with laboratory values outside of protocol defined ranges Active malignancy of a type not included in the study population requiring treatment.

• Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).

• Evidence of interstitial lung disease or active, noninfectious pneumonitis.

• Untreated or known active CNS metastases and/or carcinomatous meningitis.

• With the exception of participants with HCC, known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization).

• Active infection requiring systemic therapy.

• Receipt of systemic antibiotics within 28 days of first dose of study treatment

• Probiotic usage during screening and throughout the study treatment period.

• Participants who are known to be HIV-positive.

• Participants with impaired cardiac function or clinically significant cardiac disease.

• History or presence of an ECG finding that, in the investigator's opinion, is clinically meaningful.

• Female participant is pregnant or breastfeeding within the projected duration of the study, starting with the screening visit through the 90-day safety follow-up, or male participant is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 100 days after the last dose of study treatment.

• Has received a live vaccine within 90 days of the planned start of study drug.

• Current use of a prohibited medication as described in protocol.

• Life expectancy < 3 months.

• Known hypersensitivity or severe reaction to any component of study drug or formulation components.

• History of organ transplant, including allogeneic stem cell transplantation.

• Inability to swallow tablets or any condition of the upper gastrointestinal tract that precludes administration of oral medications.

• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Hepatocellular Carcinoma
• Melanoma
• Non Small Cell Lung Cancer
• Renal Cell Carcinoma
• Urothelial Cancer

Intervention

Drug:
• INCB086550
INCB086550 will be administered orally twice a day.

Locations

Country	Name	City	State
Bulgaria	Complex Oncology Center - Burgas Eood	Burgas
Bulgaria	Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" Jsc	Gabrovo
Bulgaria	Complex Onclogy Center Plovdiv Eood	Plovdiv
Bulgaria	Shatod Dr. Marko - Varna Ltd	Varna
Hungary	Semmelweis Egyetem	Budapest
Hungary	Complex Oncology Center - Burgas Eood	Farkasgyepu
Hungary	Bacs Kiskun Megyei Oktatokorhaz	Kecskemet
Korea, Republic of	The Catholic University of Korea St. Vincent'S Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Taiwan	Chang Gung Memorial Hospital Linkou	Taoyuan City
Ukraine	Multifield Clinical Hospital No 4	Dnipro
Ukraine	Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection	Kharkiv
Ukraine	Mi Kryviy Rih Center of Dnipropetrovsk Regional Council	Kryvyi Rih
Ukraine	Volyn Regional Oncological Dispensary	Lutsk
Ukraine	Rmi Sumy Regional Clinical Oncology Dispensary	Sumy
Ukraine	Cne Ccch of Uzh Cc Oncological Center	Uzhgorod
Ukraine	Medical Clinic Innovacia Llc	Vyshhorod

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Korea, Republic of,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment = 28 days later according to RECIST v1.1 as determined by the investigator.	up to 2 years
Secondary	Disease Control Rate	Defined as the percentage of participants with a best overall response of CR or PR confirmed by at least 1 repeat assessment = 28 days later, or SD for = 12 weeks, by investigator assessment per RECIST v1.1.	up to 2 years
Secondary	Duration of Response	Defined as the time from the earliest date of CR or PR confirmed by at least 1 repeat assessment = 28 days later until the earliest date of disease progression by investigator assessment per RECIST v1.1, or death due to any cause, if occurring sooner than progression	up to 2 years
Secondary	Safety and Tolerability of INCB86550 as Assessed by Number of Participants With a TEAE	TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.	up to 2 years