MC# 21-42 - A Phase I Study of The Safety and Tolerability of COM902 in Subjects with Advanced Malignancies
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Agent(s): COM902 & COM701
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Disease Type(s): Solid Tumor
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Phase(s): I
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Drug Classification(s): Immunotherapy, Monoclonal Antibody, Targeted Therapy
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Molecular Target(s): TIGIT, PVRIG
Mechanism of Action
COM902 is a monoclonal antibody that binds to TIGIT, an inhibitory signal molecule on certain types of lymphocytes. The inhibition of TIGIT (by COM902), either alone or in combination with inhibition of PVRIG (by COM701), may enhance antigen-specific human T cell responses.
COM701 is a monoclonal antibody against the poliovirus receptor-related immunoglobulin domain-containing (PVRIG; CD112R), a regulatory signal molecule expressed on cytotoxic T lymphocytes and NK cells. Blockade of TIGIT and PVRIG could enhance anti-tumor responses and immune-mediated tumor cell killing.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of COM902 can be given alone and in combination with COM701 and pembrolizumab with an acceptable level of side effects
- The effects of the study drugs (good and bad)
- How much of the study drug(s) are absorbed into the blood and how fast they are removed
- If research tests can be used in the future to predict who will benefit from COM902 and/or COM701
Inclusion Criteria
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy; or not a candidate for standard therapy
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
- Prior treatment with a TIGIT inhibitor
- Symptomatic interstitial lung disease or inflammatory pneumonitis
- History of immune-related events that required immunotherapy treatment discontinuation
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
