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

Primary Purpose

Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JANX008
Sponsored by
Janux Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical CenterRecruiting
  • Washington UniversityRecruiting
  • The Christ Hospital Cancer CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation

Backfill Expansion

Expansion

Arm Description

Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.

Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.

Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).

Outcomes

Primary Outcome Measures

Incidence of Dose Limiting Toxicities (DLT)
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Incidence of Clinically Significant Laboratory Abnormalities

Secondary Outcome Measures

Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Maximum observed concentration of JANX008 (Cmax)
Number of participants who develop anti-drug antibodies against JANX008
Overall Response Rate
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Duration of Response
Time from documentation of CR or PR to disease progression per RECIST v1.1
Progression Free Survival
Time from treatment initiation to disease progression per RECIST v1.1
Correlation of EGFR expression level with anti-tumor activity and safety

Full Information

First Posted
March 14, 2023
Last Updated
July 24, 2023
Sponsor
Janux Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05783622
Brief Title
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Official Title
An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janux Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, Colorectal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Arm Title
Backfill Expansion
Arm Type
Experimental
Arm Description
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
Arm Title
Expansion
Arm Type
Experimental
Arm Description
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Intervention Type
Drug
Intervention Name(s)
JANX008
Intervention Description
JANX008 is dosed via IV weekly in a 21-day cycle
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities (DLT)
Time Frame
21 days
Title
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame
Up to 4 years
Title
Incidence of Clinically Significant Laboratory Abnormalities
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Number of participants who develop anti-drug antibodies against JANX008
Time Frame
Up to 4 years
Title
Overall Response Rate
Description
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Time Frame
Up to 4 years
Title
Duration of Response
Description
Time from documentation of CR or PR to disease progression per RECIST v1.1
Time Frame
Up to 4 years
Title
Progression Free Survival
Description
Time from treatment initiation to disease progression per RECIST v1.1
Time Frame
Up to 4 years
Title
Correlation of EGFR expression level with anti-tumor activity and safety
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janux Therapeutics
Phone
858-751-4493
Email
EGFR-008-001@januxrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janux Therapeutics, MD
Organizational Affiliation
Janux Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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