Locally Advanced Solid TumorsPhase 1NCT03059823
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
A Phase 1 study testing retifanlimab in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Incyte Corporation at 80 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumors, Metastatic Solid Tumors
- What is being tested?
- retifanlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 80 sitesin 16 countries
- Study dates
- 15 Nov 2016to 22 May 2024
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
80 sites in 16 countries.
80 sites in 16 countries
China17 sites
Peking Union Medical College Hospital
Beijing, 100000
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Beijing Cancer Hospital
Beijing, 100142
Peking University Third Hospital
Beijing, 100191
Xiangya Hospital Central South University
Changsha, 410008
Hunan Cancer Hospital
Changsha, 410013
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, 510000
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, 510080
Qilu Hospital of Shandong University
Jinan, 250000
Yunnan Cancer Hospital
Kunming, 650118
Zhongda Hospital Southeast University
Nanjing, 210009
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 50010
The Second Hospital of Shanxi Medical University
Taiyuan, 30001
Tongji Hospital Huazhong University of Science and Technology
Wuhan, 430030
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
The First Affiliated Hospital of Xiamen University
Xiamen, 361000
Henan Cancer Hostipal
Zhengzhou, 450003
Poland9 sites
SZPITALE WOJEW�DZKIE W GDYNI SP�LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA
Gdynia, 81-519
University Hospital Krakow, Department of Oncology
Krakow, 31-501
Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie
Lublin, 20-362
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie
Olsztyn, 10-357
Biovirtus Research Site
Otwock, 05-400
Szpital Kliniczny Przemienienia Panskiego
Poznan, 06056
Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej
Poznan, 60-569
Medical University of Warsaw - 2Nd Department Obstetric and Gynecology
Warsaw, 00-315
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
Warsaw, 02-781
United States8 sites
South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, 49546
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina, 28078
Rutgers Cancer Institute of Nj
New Brunswick, New Jersey, 08901
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Honor Health Research Institute
Scottsdale, Arizona, 85258
France8 sites
Institut Bergonie
Bordeaux, 33000
Centre Leon Berard
Lyon, 69373
Centre Antoine Lacassagne
Nice, 06189
Hospital Universitaires de Geneve
Paris, 75014
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
Saint-Herblain, 44800
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94800
Germany7 sites
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117
CHARITE - UNIVERSIT�TSMEDIZIN BERLIN
Berlin, 13353
University Clinic Carl Gustav Carus Technical University Dresden
Dresden, 01307
Universitatsklinikum Essen
Essen, 45147
University Medical Center Freiburg
Freiburg im Breisgau, 79106
STADTISCHE KLINIKUM MUNCHEN � NEUPERLACH KLINIK FUR HAMATOLOGIE UND ONKOLOGIE
München, 81737
University Hospital Grosshadern Munich
Munich, 81377
Spain5 sites
Hospital General Universitario Vall D Hebron
Barcelona, 08035
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario de La Paz
Madrid, 28046
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid, 28050
Ukraine5 sites
Multifield Clinical Hospital No 4
Dnipro, 49102
Regional Clinical Oncology Center Facility of State Higher Educational Institution
Ivano-Frankivsk, 76000
Rmi Sumy Regional Clinical Oncology Dispensary
Sumy, 40030
Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital
Uzhhorod, 08800
Podillia Regional Center of Oncology - Chemotherapy Department
Vinnytsia, 21000
Bulgaria4 sites
COMPLEX ONCOLOGY CENTER � BURGAS EOOD
Burgas, 08000
Mc Women'S Health-Nadezhda Eood
Sofia, 01330
Acibadem Cityclinica Mhat Tokuda
Sofia, 01407
Umhat in Oncology
Sofia, 01756
Italy4 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, 60126
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
Candiolo, 10060
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
United Kingdom3 sites
Sarah Cannon Research Institute
London, W1G 6AD
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BX
The Royal Marsden Nhs Foundation Trust - Chelsea
Sutton, SM2 5PT
Australia2 sites
Chris Obrien Lifehouse
Camperdown, New South Wales, 02050
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales, 02010
Belgium2 sites
Universitair Ziekenhuis (Uz) Leuven
Leuven, 03000
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 04000
Finland2 sites
Docrates Cancer Center
Helsinki, 00180
Turku University Hospital
Turku, 20521
New Zealand2 sites
Auckland City Hospital
Auckland, 01023
Wellington Hospital
Wellington, 06021
About this study
Official title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors
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.
Read the detailed description
This study is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of INCMGA00012 administered IV every 2, 3, or 4 weeks in patients with relapsed/refractory, unresectable locally advanced or metastatic solid tumors.
In the initial phase of the study, two dose schedules will be assessed in dose escalation, once every two weeks and once every four weeks administration of single agent INCMGA00012. Following the establishment of an MTD, additional patients will enroll in expansion cohorts of specific tumor types and/or INCMGA00012 dose.
The Cohort Expansion Phase will include tumor-specific cohorts, consisting of patients with endometrial cancer (unselected [up to n = 35] and MSI-H or dMMR [up to n = 70]), cervical cancer (up to n = 35), sarcoma (up to n = 35), non-small cell lung cancer (NSCLC) (up to n = 35), and 3 cohorts of any tumor histology (tumor-agnostic) (up to n = 15) who will receive flat dosing: 1 cohort treated with INCMGA00012 500 mg Q4W, 1 cohort with INCMGA00012 750 mg Q4W, and 1 cohort treated with INCMGA00012 375 mg Q3W.
- Being tested
- retifanlimab
- Keywords
- Solid tumors, Metastatic cancer
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retifanlimabDrug
Also called INCMGA0012
Anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation-Q2W | Experimental | INCMGA00012 treatment once every 2 weeks. Receives: Drug: retifanlimab |
| Dose Escalation- Q3W | Experimental | INCMGA00012 treatment once every 3 weeks. Receives: Drug: retifanlimab |
| Dose Escalation- Q4W | Experimental | INCMGA00012 treatment once every 4 weeks. Receives: Drug: retifanlimab |
| Expansion Cohort | Experimental | INCMGA00012 treatment for locally advanced or metastatic solid tumors. Receives: Drug: retifanlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
MTD
Maximum Tolerated Dose of INCMGA00012
Measured: 24 months
Secondary outcomes (8)
AUC
Area Under the Plasma Concentration versus Time Curve of INCMGA00012
Measured: 24 months
Cmax
Maximum Plasma Concentration of INCMGA00012
Measured: 24 months
Tmax
Time to reach maximum (peak) plasma concentration of INCMGA00012
Measured: 24 months
Ctrough
Trough plasma concentration of INCMGA00012
Measured: 24 months
Total body clearance of the drug from plasma (CL) of INCMGA00012
Measured: 24 months
Vss
Apparent volume of distribution at steady state of INCMGA00012
Measured: 24 months
t1/2
Terminal half-life of INCMGA00012
Measured: 24 months
ADA
Percent of patients with anti-drug antibody
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start15 Nov 2016
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059823
- Sponsor's protocol ID
- INCMGA 0012-101
- Other IDs
- 2017-000865-63, 2017
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2017
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03059823
- Acronym / sponsor ID
- INCMGA 0012-101
- Keywords
- Solid tumors, Metastatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Phase 1, open-label, dose escalation and cohort expansion study designed to characterize the safety, tolerability, PK, PD, immunogenicity, and preliminary anti-tumor activity of INCMGA00012 administered IV every 2, 3, or 4 weeks in patients with relapsed/refractory, unresectable locally advanced or metastatic solid tumors.
In the initial phase of the study, two dose schedules will be assessed in dose escalation, once every two weeks and once every four weeks administration of single agent INCMGA00012. Following the establishment of an MTD, additional patients will enroll in expansion cohorts of specific tumor types and/or INCMGA00012 dose.
The Cohort Expansion Phase will include tumor-specific cohorts, consisting of patients with endometrial cancer (unselected [up to n = 35] and MSI-H or dMMR [up to n = 70]), cervical cancer (up to n = 35), sarcoma (up to n = 35), non-small cell lung cancer (NSCLC) (up to n = 35), and 3 cohorts of any tumor histology (tumor-agnostic) (up to n = 15) who will receive flat dosing: 1 cohort treated with INCMGA00012 500 mg Q4W, 1 cohort with INCMGA00012 750 mg Q4W, and 1 cohort treated with INCMGA00012 375 mg Q3W.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation-Q2W | Experimental | Drug: retifanlimabINCMGA00012 treatment once every 2 weeks. |
| Dose Escalation- Q3W | Experimental | Drug: retifanlimabINCMGA00012 treatment once every 3 weeks. |
| Dose Escalation- Q4W | Experimental | Drug: retifanlimabINCMGA00012 treatment once every 4 weeks. |
| Expansion Cohort | Experimental | Drug: retifanlimabINCMGA00012 treatment for locally advanced or metastatic solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retifanlimabAlso: INCMGA0012Anti-PD-1 monoclonal antibody | Drug | Dose Escalation- Q3W, Dose Escalation- Q4W, Dose Escalation-Q2W, Expansion Cohort |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03
Time frame: 24 months
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.
MTD
Time frame: 24 months
Maximum Tolerated Dose of INCMGA00012
8 secondary outcomes
AUC
Time frame: 24 months
Cmax
Time frame: 24 months
Tmax
Time frame: 24 months
Ctrough
Time frame: 24 months
Total body clearance of the drug from plasma (CL) of INCMGA00012
Time frame: 24 months
Vss
Time frame: 24 months
t1/2
Time frame: 24 months
ADA
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
80 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing retifanlimab in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Incyte Corporation at 80 sites in 16 countries.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in China, Poland, United States, France, Germany and 11 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.