Colorectal Carcinoma, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Renal Cell Carcinoma, Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Triple-negative Breast Cancer
Conditions
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.
Interventions
DRUGJANX008
JANX008 is dosed via IV weekly in a 21-day cycle
Sponsors
Janux Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose Limiting Toxicities (DLT) | 21 days |
| Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 4 years |
| Incidence of Clinically Significant Laboratory Abnormalities | Up to 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last) | 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) | 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 | Up to 4 years | — |
| Overall Response Rate | Up to 4 years | Proportion of participants who achieve a complete response or partial response per RECIST v1.1 |
| Duration of Response | Up to 4 years | Time from documentation of CR or PR to disease progression per RECIST v1.1 |
| Progression Free Survival | Up to 4 years | Time from treatment initiation to disease progression per RECIST v1.1 |
| Correlation of EGFR expression level with anti-tumor activity and safety | Up to 4 years | — |
Countries
United States
Contacts
STUDY_DIRECTORJanux Therapeutics, MD
Janux Therapeutics
Outcome results
None listed