Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
NCT ID: NCT05783622
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2023-04-19
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Backfill Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Interventions
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JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, RCC, SCLC, PDAC, TNBC
* Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
* Adequate organ function
* At least 1 measurable lesion per RECIST 1.1
Exclusion Criteria
* Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
* Prior treatment with CD3 engaging bispecific antibodies
* Clinically significant cardiovascular diseases
* Active clinically significant infection (bacterial, viral, fungal, mycobacteria, or other)
* On supplemental oxygen
* Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment
18 Years
100 Years
ALL
No
Sponsors
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Janux Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Janux Therapeutics, MD
Role: STUDY_DIRECTOR
Janux Therapeutics
Locations
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City of Hope Medical Center
Duarte, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California San Diego Moores Cancer Center
San Diego, California, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Laura and Isaac Perlmutter Cancer Center NYU Langone Health
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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EGFR-008-001
Identifier Type: -
Identifier Source: org_study_id
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