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An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

To determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®)

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team and fill out questionnaires. The study also involves blood draws and willingness to take the study medication regularly.

In-person visits:
About 10

Total length of participation:
About 8 months

Looking for Specific Volunteers

Able to participate:

Locally Advanced or Metastatic Solid Tumors of the Head or Neck
At least 18 years old

Not eligible if:

Disease amenable for local therapy administered with curative intent.
Primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
Progressive disease within 6 months of completion of curatively intended treatment for locoregionally advanced HNSCC.
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
Prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for recurrent or metastatic HNSCC.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

NC Memorial Hospital
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sid Sheth
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

24-1877

ClinicalTrials.gov

NCT04198766

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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