A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1/2 Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949632
• Other study ID #: INCB99280-201
• Secondary ID: 2022-003663-13
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 16, 2024
• Est. completion date: December 15, 2027

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (ex-US)
• Phone: +800 00027423
• Email: eumedinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: December 15, 2027
• Est. primary completion date: December 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered non-amenable to surgery or other curative treatments or procedures.
• Must have disease progression on or after treatment with at least one prior systemic chemotherapy.
• Eastern Cooperative Oncology Group performance status score of 0 or 1.
• Life expectancy > 12 weeks.
• Willingness to avoid pregnancy.

Exclusion Criteria:

• Known additional malignancy that is progressing or requires active treatment.
• Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
• Toxicity from prior therapy that has not recovered to protocol-defined limits.
• Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
• Prior therapy with antiangiogenic small-molecule TKIs targeting the VEGF pathway
• Participation in another interventional clinical study while receiving INCB099280.
• Impaired cardiac function or clinically significant cardiac disease.
• History or evidence of interstitial lung disease including noninfectious pneumonitis.
• Presence of gastrointestinal conditions that may affect drug absorption.
• Any autoimmune disease requiring systemic treatment in the past 5 years.
• Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
• Active infection requiring systemic therapy.
• History of organ transplantation, including stem cell transplantation.
• Receipt of systemic antibiotics within 28 days of first dose of study treatment.
• Probiotic usage is prohibited during screening and throughout the study treatment period.
• Received a live vaccine within 28 days of the planned start of study drug.
• Laboratory values outside the Protocol-defined ranges.
• Inadequate organ function. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• INCB099280
Administered as specified in the treatment arm description
• axitinib
Administered as specified in the treatment arm description

Locations

Country	Name	City	State
Hungary	Orszagos Onkologiai Intezet	Budapest
Spain	Clinica Mi Tres Torres	Barcelona
Spain	Hospital Clinic Barcelona Main	Barcelona
Spain	Hospital General Universitario Vall D Hebron	Barcelona
Spain	Hospital Hm Nou Delfos	Barcelona
Spain	Hospital Quironsalud Barcelona	Barcelona
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	Clinical Universidad de Navarra Madrid	Madrid
Spain	Fundacion Jimenez Diaz University Hospital	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Clinica Universidad de Navarra (Cun)	Pamplona
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Beatson West of Scotland Cancer Centrewester	Glasgow
United Kingdom	Guys Hospital	London
United Kingdom	St Bartholomew'S Hospital	London
United Kingdom	The Royal Marsden	London
United Kingdom	The Royal Marsden Nhs Foundation Trust - Sutton	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

Hungary,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of participants with Dose Limiting Toxicities (DLTs)	Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.	Up to 21 days
Primary	Part 1: Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 2 years and 90 days
Primary	Part 1: Number of participants with TEAEs leading to dose modification	Number of participants with TEAEs leading to a dose modification (treatment interruption, dose reduction, and permanent discontinuation of either study drug).	Up to 2 years
Primary	Part 2: Objective response rate (ORR)	Defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2 years
Secondary	Part 2: Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 2 years and 90 days
Secondary	Part 2: Number of participants with TEAEs leading to dose modification	Number of participants with TEAEs leading to a dose modification (treatment interruption, dose reduction, and permanent discontinuation of either study drug).	Up to 2 years
Secondary	Part 1: Objective response rate (ORR)	Defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 2 years
Secondary	Disease Control Rate (DCR)	Defined as the best overall response of CR, PR, or stable disease (SD) of at least 11 weeks from the start of treatment by investigator assessment per RECIST v1.1.	Up to 2 years
Secondary	Duration of Response (DOR)	Defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurs earlier.	Up to 2 years
Secondary	INCB099280 and axitinib plasma concentrations.	PK parameters will be calculated from the blood plasma concentrations of INCB099280 and axitinib using standard noncompartmental (model independent) PK methods.	Up to 2 years