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

NCT03059823 | Completed Phase 1 FDA Drug

• 2 other identifiers: INCMGA 0012-1012017-000865-63
• Study Type: interventional
• Target: 325
• Locations: 16 countries
• Sites: 80

Brief Summary

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.

Conditions

Locally Advanced Solid Tumors; Metastatic Solid Tumors

Keywords

Solid tumors; Metastatic cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03

  Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

  24 months

• MTD

  Maximum Tolerated Dose of INCMGA00012

  24 months

Secondary Outcomes (8)

• AUC

  24 months

• Cmax

  24 months

• Tmax

  24 months

• Ctrough

  24 months

• Total body clearance of the drug from plasma (CL) of INCMGA00012

  24 months

Study Arms (4)

Dose Escalation-Q2W

EXPERIMENTAL

INCMGA00012 treatment once every 2 weeks.

Drug: retifanlimab

Dose Escalation- Q3W

EXPERIMENTAL

INCMGA00012 treatment once every 3 weeks.

Drug: retifanlimab

Dose Escalation- Q4W

EXPERIMENTAL

INCMGA00012 treatment once every 4 weeks.

Drug: retifanlimab

Expansion Cohort

EXPERIMENTAL

INCMGA00012 treatment for locally advanced or metastatic solid tumors.

Drug: retifanlimab

Interventions

retifanlimab DRUG

Anti-PD-1 monoclonal antibody

Also known as: INCMGA0012

Dose Escalation- Q3W; Dose Escalation- Q4W; Dose Escalation-Q2W; Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (80)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

South Texas Accelerated Research Therapeutics

Grand Rapids, Michigan, 49546, United States

Location

Rutgers Cancer Institute of Nj

New Brunswick, New Jersey, 08901, United States

Location

Carolina Bio-Oncology Institute, Pllc

Huntersville, North Carolina, 28078, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 02050, Australia

Location

St Vincent'S Hospital Sydney

Darlinghurst, New South Wales, 02010, Australia

Location

Universitair Ziekenhuis (Uz) Leuven

Leuven, 03000, Belgium

Location

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000, Belgium

Location

COMPLEX ONCOLOGY CENTER � BURGAS EOOD

Burgas, 08000, Bulgaria

Location

Mc Women'S Health-Nadezhda Eood

Sofia, 01330, Bulgaria

Location

Acibadem Cityclinica Mhat Tokuda

Sofia, 01407, Bulgaria

Location

Umhat in Oncology

Sofia, 01756, Bulgaria

Location

Peking Union Medical College Hospital

Beijing, 100000, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Xiangya Hospital Central South University

Changsha, 410008, China

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

Guangzhou, 510000, China

Location

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, 510080, China

Location

Qilu Hospital of Shandong University

Jinan, 250000, China

Location

Yunnan Cancer Hospital

Kunming, 650118, China

Location

Zhongda Hospital Southeast University

Nanjing, 210009, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, 50010, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, 30001, China

Location

Tongji Hospital Huazhong University of Science and Technology

Wuhan, 430030, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, 361000, China

Location

Henan Cancer Hostipal

Zhengzhou, 450003, China

Location

Docrates Cancer Center

Helsinki, 00180, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hospital Universitaires de Geneve

Paris, 75014, France

Location

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75020, France

Location

Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

Saint-Herblain, 44800, France

Location

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

CHARITE - UNIVERSIT�TSMEDIZIN BERLIN

Berlin, 13353, Germany

Location

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Essen

Essen, 45147, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Grosshadern Munich

Munich, 81377, Germany

Location

STADTISCHE KLINIKUM MUNCHEN � NEUPERLACH KLINIK FUR HAMATOLOGIE UND ONKOLOGIE

München, 81737, Germany

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, 60126, Italy

Location

Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

Candiolo, 10060, Italy

Location

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, 80131, Italy

Location

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168, Italy

Location

Riga East University Hospsital

Riga, LV1079, Latvia

Location

National Cancer Institute

Vilnius, LT-08660, Lithuania

Location

Auckland City Hospital

Auckland, 01023, New Zealand

Location

Wellington Hospital

Wellington, 06021, New Zealand

Location

SZPITALE WOJEW�DZKIE W GDYNI SP�LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

Gdynia, 81-519, Poland

Location

University Hospital Krakow, Department of Oncology

Krakow, 31-501, Poland

Location

Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie

Lublin, 20-362, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie

Olsztyn, 10-357, Poland

Location

Biovirtus Research Site

Otwock, 05-400, Poland

Location

Szpital Kliniczny Przemienienia Panskiego

Poznan, 06056, Poland

Location

Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej

Poznan, 60-569, Poland

Location

Medical University of Warsaw - 2Nd Department Obstetric and Gynecology

Warsaw, 00-315, Poland

Location

Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

Warsaw, 02-781, Poland

Location

Hospital General Universitario Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Centro Integral Oncologico Clara Campal (Ciocc)

Madrid, 28050, Spain

Location

Multifield Clinical Hospital No 4

Dnipro, 49102, Ukraine

Location

Regional Clinical Oncology Center Facility of State Higher Educational Institution

Ivano-Frankivsk, 76000, Ukraine

Location

Rmi Sumy Regional Clinical Oncology Dispensary

Sumy, 40030, Ukraine

Location

Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital

Uzhhorod, 08800, Ukraine

Location

Podillia Regional Center of Oncology - Chemotherapy Department

Vinnytsia, 21000, Ukraine

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

The Christie Nhs Foundation Trust Uk

Manchester, M20 4BX, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Chelsea

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: November 15, 2016
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (9); FR (8); US (8); CN (17); NZ (2); DE (7); IT (4); LA (1); BU (4); ES (5); UA (5); FI (2); GB (3); AU (2); BE (2); LI (1)