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Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

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ClinicalTrials.gov Identifier: NCT05783622
Recruitment Status : Recruiting
First Posted : March 24, 2023
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Janux Therapeutics

Study Description
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Brief Summary:
This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Renal Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Colorectal Carcinoma Drug: JANX008 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : October 2027

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
 Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Experimental: Backfill Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
 Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Experimental: Expansion
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
 Drug: JANX008
JANX008 is dosed via IV weekly in a 21-day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: 21 days ]
  2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to 4 years ]
  3. Incidence of Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last) [ Time Frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years) ]
  2. Maximum observed concentration of JANX008 (Cmax) [ Time Frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years) ]
  3. Number of participants who develop anti-drug antibodies against JANX008 [ Time Frame: Up to 4 years ]
  4. Overall Response Rate [ Time Frame: Up to 4 years ]
    Proportion of participants who achieve a complete response or partial response per RECIST v1.1

  5. Duration of Response [ Time Frame: Up to 4 years ]
    Time from documentation of CR or PR to disease progression per RECIST v1.1

  6. Progression Free Survival [ Time Frame: Up to 4 years ]
    Time from treatment initiation to disease progression per RECIST v1.1

  7. Correlation of EGFR expression level with anti-tumor activity and safety [ Time Frame: Up to 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ≥18 years of age at the time of signing informed consent
  • Histologically or cytologically documented locally advanced or metastatic NSCLC, SCCHN, CRC, or RCC
  • 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:

  • Treatment with anti-cancer therapy within 28 days or ≤5 elimination half-lives, whichever is earlier, before enrollment
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05783622


Contacts
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Contact: Janux Therapeutics 858-751-4493 EGFR-008-001_ct.gov@januxrx.com

Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
University of California San Diego Moores Cancer Center Recruiting
San Diego, California, United States, 92093
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Christ Hospital Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Janux Therapeutics
Investigators
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Study Director: Janux Therapeutics, MD Janux Therapeutics
More Information
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Responsible Party: Janux Therapeutics
ClinicalTrials.gov Identifier: NCT05783622    
Other Study ID Numbers: EGFR-008-001
First Posted: March 24, 2023    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma, Squamous Cell
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases