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

April 18, 2024 updated by: Janux Therapeutics

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California San Diego Moores Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital Cancer Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose Limiting Toxicities (DLT)
Time Frame: 21 days
21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: Up to 4 years
Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
Number of participants who develop anti-drug antibodies against JANX008
Time Frame: Up to 4 years
Up to 4 years
Overall Response Rate
Time Frame: Up to 4 years
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Up to 4 years
Duration of Response
Time Frame: Up to 4 years
Time from documentation of CR or PR to disease progression per RECIST v1.1
Up to 4 years
Progression Free Survival
Time Frame: Up to 4 years
Time from treatment initiation to disease progression per RECIST v1.1
Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janux Therapeutics

Investigators

  • Study Director: Janux Therapeutics, MD, Janux Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGFR-008-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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