This study will test a Regeneron drug called REGN13089-M404-M2980 ("study drug") to see if it can help treat previously treated, advanced solid tumors (tumors that have grown and spread to different areas of the body).
The study is focused on advanced cancers that have more of a protein called mesenchymal epithelial transition factor (MET) on the surface of their cells than usual. The study drug works by binding to MET on tumor cells and delivering chemotherapy directly into those cells. This may stop growth of the cancer cells and kill only the cancer cells and not the other normal tissues in your body. However, some of the chemotherapy may still affect the normal cells and side effects can still occur.
The study is looking at:
* What side effects the study drug might cause * How well the study drug works * How much of the study drug is in the blood at different times * If the body reacts to the study drug, in a way that may cause the study drug to not work as well * What is the best dose of the study drug for treating previously treated, advanced solid tumors
Histologically confirmed cancer (non-small cell lung cancer (epidermal growth factor receptor mutant type or epidermal growth factor receptor mutant type), colorectal cancer, gastric/gastroesophageal junction cancer, uveal melanoma, papillary renal cell carcinoma, or clear cell renal cell carcinoma) that is at an advanced stage as described in the protocol
Participants must not be candidates for curative surgery or radiation
Participants are required to have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, or intolerance of the therapy as described in the protocol
Willing to provide tumor tissue; archival or fresh tumor tissue will be accepted as described in the protocol
Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device as described in the protocol
Has received radiation therapy within the 28 days prior to first administration of study intervention. Palliative stereotactic radiation therapy without a thoracic or abdominal field is allowed with a washout period of 14 days from first administration of study intervention.
Has undergone major surgery within the 14 days prior to first administration of study intervention
Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy as described in the protocol
Sequential
REGN13089-M404-M2980
DrugAdministered per the protocol
Occurrence of dose-limiting toxicities (DLTs)
Part 1 (Dose Escalation)
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Part 1 (Dose Escalation)
Occurrence of Serious Adverse Events (SAEs)
Part 1 (Dose Escalation)
Occurrence of adverse event of special interests (AESIs)
Part 1 (Dose Escalation)
Objective response (investigator assessed) per RECIST 1.1
Part 1 (Dose Escalation)
Concentrations of ADC
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Concentrations of total antibody
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Concentrations of payload (ProDXd and DXd)
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
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This trial is not recruiting at the moment. You can still explore other options:
