INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unresectable or Metastatic Solid Tumors

In brief

The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.

Key facts

Study ID

NCT03589651

Run by

Incyte Corporation

People needed

83

Starts

2018-08-17

Expected to finish

2022-11-21

Last updated by the study team

2023-02-21

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 participants who are intolerant to or have declined standard therapy
• Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
• Willing to provide fresh or archival tumor tissue for correlative studies.
• Eastern Cooperative Oncology Group performance status 0 to 1.
• Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

You may not qualify if…

• Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
• Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
• Laboratory values outside the protocol-defined range at screening.
• Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
• Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
• Evidence of interstitial lung disease or active, noninfectious pneumonitis.

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• University of Florida - Shands Cancer Center — Gainesville, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Rutgers Cancer Institute of Nj — New Brunswick, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Upmc Cancercenter — Pittsburgh, Pennsylvania, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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