A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Locally Advanced Solid Tumors, Metastatic Solid Tumors

In brief

The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

Key facts

Study ID

NCT03059823

Run by

Incyte Corporation

People needed

325

Starts

2016-11-15

Expected to finish

2024-05-22

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods and must also have tissue (fresh or archival) available for central confirmation of diagnosis
• Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy ≥ 12 weeks
• Measurable disease
• Acceptable laboratory parameters

You may not qualify if…

• Symptomatic central nervous system (CNS) metastases.
• For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study.
• Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
• Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug administration.
• Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
• Clinically significant cardiovascular disease
• Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
• Presence of active pneumonitis or history of non-infectious pneumonitis.
• Clinically significant gastrointestinal disorders
• Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug
• Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
• Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
• Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
• Dementia or altered mental status that would preclude understanding and rendering of informed consent

Where it is running

• South Texas Accelerated Research Therapeutics — Grand Rapids, Michigan, United States
• Rutgers Cancer Institute of Nj — New Brunswick, New Jersey, United States
• Carolina Bio-Oncology Institute, Pllc — Huntersville, North Carolina, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Texas Md Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States
• Chris Obrien Lifehouse — Camperdown, New South Wales, Australia
• St Vincent'S Hospital Sydney — Darlinghurst, New South Wales, Australia
• Universitair Ziekenhuis (Uz) Leuven — Leuven, Belgium
• Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège, Belgium
• COMPLEX ONCOLOGY CENTER � BURGAS EOOD — Burgas, Bulgaria
• Mc Women'S Health-Nadezhda Eood — Sofia, Bulgaria
• Acibadem Cityclinica Mhat Tokuda — Sofia, Bulgaria
• Umhat in Oncology — Sofia, Bulgaria
• Peking Union Medical College Hospital — Beijing, China
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China
• Beijing Cancer Hospital — Beijing, China
• Peking University Third Hospital — Beijing, China
• Xiangya Hospital Central South University — Changsha, China
• Hunan Cancer Hospital — Changsha, China
• Sun Yat-Sen Memorial Hospital Sun Yat-Sen University — Guangzhou, China
• The First Affiliated Hospital Sun Yat-Sen University — Guangzhou, China
• Qilu Hospital of Shandong University — Jinan, China
• Honor Health Research Institute — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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