A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
Recruiting
Phase 1
Phase 2
Interventional Study
Melanoma
Clear-Cell Renal-Cell Carcinoma (ccRCC)
Advanced Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe, tolerable, and effective the study drug(s) are.
The study is looking at several other research questions, including:
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Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
Dose escalation cohorts:
1\. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available
Dose expansi…
Contacts