Study Details

Open

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-IL2RA-IL2 FUSION PROTEIN) IN PATIENTS WITH ADVANCED SOLID ORGAN MALIGNANCIES

The study is enrolling participants to see if the study drug REGN10597 is safe, tolerated, and effective in certain solid tumors that are in an advanced stage.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study includes blood draws, physician exams, CT or MRI scans, ECG's, Echocardiograms, Pulmonary Function test, and study treatment.

Incentives

Study medication

In-person visits:
More than 10

Phone or online visits:
survival follow-up every 4 months

Total length of participation:
up to 3 years

Looking for Specific Volunteers

Able to participate:

YOu have an expected survival of at least 3 months per investigator judgement.
You have a histologically or cytologically confirmed diagnosis of malignancy with confirmed progression on standard of care therapy.
You have adequate cardiac function based on results from a stress echocardiogram, MUGA scan, or transthoracic echocardiogram.
You have adequate organ, bone marrow, and hepatic function as documented by specific lab values.
Your oxygen saturation greater than or equal to 92% on room air.

Not eligible if:

You have participated in any study of an investigation agent or device within 4 weeks of first study drug administration.
You have received treatment with an approved systemic therapy within 4 weeks of first study drug administration.
You have received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not recovered from adverse events.
You have received prior anti-cancer immunotherapy within 2 months prior to study therapy.
You have untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Tracy Rose
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Bladder, Kidney)

IRB Number

24-1479

ClinicalTrials.gov

NCT06413680