A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors Carcinoma

Updated on 10 May 2022
solid tumors


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.

Condition Cancer/Tumors
Clinical Study IdentifierTX223523
Last Modified on10 May 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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