Clinical trial NCT05783622: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Squamous Cell Carcinoma of the Head and Neck
Colorectal Carcinoma
Small Cell Lung Cancer
Pancreatic Ductal Adenocarcinoma
Triple-negative Breast Cancer
Lead sponsor: Janux Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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, 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:

* 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

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities (DLT)
timeFrame: 21 days
measure: Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to 4 years
measure: Incidence of Clinically Significant Laboratory Abnormalities
timeFrame: Up to 4 years
Secondary outcomes:
measure: Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
timeFrame: 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)
measure: Maximum observed concentration of JANX008 (Cmax)
timeFrame: 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)
measure: Number of participants who develop anti-drug antibodies against JANX008
timeFrame: Up to 4 years
measure: Overall Response Rate
timeFrame: Up to 4 years
measure: Duration of Response
timeFrame: Up to 4 years
measure: Progression Free Survival
timeFrame: Up to 4 years
measure: Correlation of EGFR expression level with anti-tumor activity and safety
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania, Abramson Cancer Center
state: Pennsylvania
city: Pittsburg
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Janux Therapeutics
name: Janux Therapeutics, MD
role: STUDY_DIRECTOR
References: