Study on INBRX-106 Alone and with Pembrolizumab (Keytruda®) for Advanced Solid Tumors

Sponsor: Inhibrx Biosciences, Inc

Sponsor score: 0

ClinicalTrials ID:NCT04198766

This clinical trial is testing the safety and best dose of a new drug, INBRX-106, alone and in combination with pembrolizumab (Keytruda®), for adults with advanced solid tumors that cannot be surgically removed.

Patient Parameters

Program Overview

This study is in two phases and aims to find out how safe INBRX-106 is and what dose works best when used alone or with pembrolizumab (Keytruda®) in treating advanced solid tumors. The trial is open-label, meaning both the researchers and participants know what treatment is being given. It is non-randomized, so all participants receive the treatment being studied.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have advanced solid tumors that cannot be surgically removed and have worsened despite standard treatments, or no other standard treatments are available.
  • For certain parts of the study, participants must have specific types of cancer like non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, stomach cancer, kidney cancer, or bladder cancer.
  • Must have good blood, liver, and kidney function and be in generally good health.
  • For some groups, participants must have specific genetic markers or have tried certain treatments before.
  • Must not have certain genetic mutations if they have non-squamous NSCLC.
  • Must meet specific criteria for PD-L1 protein levels in their tumors.

Exclusion Criteria

  • Have previously been treated with OX40 agonists.
  • Have received other cancer treatments or investigational drugs recently, with some exceptions.
  • Have blood cancers or other types of cancer that could interfere with the study.
  • Have active cancer in the brain or spinal cord, unless treated and stable.
  • Have had severe immune-related side effects from previous treatments.
  • Have active autoimmune diseases requiring treatment with steroids or other medications.
  • Have a history of certain infections like hepatitis B, hepatitis C, or HIV, unless exceptions apply.
  • Have lung diseases like interstitial lung disease or pneumonitis.
  • Have serious heart conditions or uncontrolled high blood pressure.
  • Have had a significant blood clot in the lungs recently.
  • Have had major surgery recently.
  • Have had recent treatments for infections.
  • Have had organ or stem cell transplants.

Locations

FACILITYZIPCITYSTATE
City of Hope91010DuarteCalifornia
Valkyrie Clinical Trials90069Los AngelesCalifornia
Winship Cancer Institute - Emory University30322AtlantaGeorgia
The University of Chicago Medical Center60637ChicagoIllinois
University of Iowa52242Iowa CityIowa
Norton Cancer Institute40202LouisvilleKentucky
Henry Ford Cancer Institute48202DetroitMichigan
START Midwest49546Grand RapidsMichigan
Nebraska Cancer Specialists68130OmahaNebraska
Providence Portland Medical Center97213PortlandOregon

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