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REGNRegeneron PharmaceuticalsSigning up patients

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

Melanoma · Clear-Cell Renal-Cell Carcinoma (ccRCC) · Advanced Solid Tumors

5Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

  • 5 insiders sold shares within a month

    Since Nov 4, 2026 · was worth 5, fading over time

    +4.8
Worry score5

Score over time

Stage
Phase 1/2
Patients
240 (planned)
Started
Sep 23, 2024
Main results expected
Feb 3, 2030
Fully finished
Feb 3, 2030
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Incidence of Dose-Limiting Toxicities (DLTs)

    Measured over: Up to Day 29

  • Incidence of Treatment-Emergent Adverse Event (TEAEs)

    Measured over: Approximately 6 Years

  • Incidence of Serious Adverse Events (SAEs)

    Measured over: Approximately 6 Years

  • Incidence of TEAEs leading to treatment discontinuation

    Measured over: Approximately 6 Years

  • Incidence of TEAEs leading to death

    Measured over: Approximately 6 Years

  • Number of participants with Grade 3 laboratory abnormalities

    Measured over: Approximately 6 Years

  • Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment

    Measured over: Approximately 6 Years

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • insider_selling_cluster: base 5, now 4.8, since 2026-11-04, fades (half-life)

Raw record changes

  • none yet

Trial ID NCT06413680 · record last updated 2026-04-28 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06413680) ↗