Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Adil Daud (ucsf)

Description

Summary

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:

  • What side effects may happen from taking the study drug(s)
  • How much study drug(s) is in the blood at different times
  • Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Official Title

A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies

Details

Phase 1: Conducted in the United States only Phase 2: Conducted globally

Keywords

Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors, Advanced solid organ malignancies, Locally advanced, Metastatic, Non-uveal, Unresectable, Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1), Renal Cell Carcinoma, Neoplasm Metastasis, cemiplimab, REGN10597

Eligibility

You can join if…

Open to people ages 18 years and up

Dose escalation cohorts:

  1. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
  2. Participants are required to submit archival tissue if it is available

Dose expansion cohorts:

  1. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
    • Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
    • Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
    • Module 2, Cohort 1: 1L Melanoma
  2. ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points

You CAN'T join if...

  1. Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
  2. Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
  3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
  4. Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, and discontinuation due to grade 3 or 4 toxicities
  5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
  6. Has known allergy or hypersensitivity to components of the study drug(s)
  7. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention
  8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

Locations

  • University of California San Francisco (UCSF) accepting new patients
    San Francisco California 94143 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90089 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
Links
BrILliance
ID
NCT06413680
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated