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

Phase 1

Recruiting

• 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
• Interventions: Drug: JANX008

• Registration Number: NCT05783622
• Lead Sponsor: Janux Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-24
• Study Start: 2023-04-19
• Status Verified: 2024-09
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-01
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Expansion	JANX008	Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Dose Escalation	JANX008	Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Backfill Expansion	JANX008	Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (12)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

University of California San Diego Moores Cancer Center; 🇺🇸 San Diego, California, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

The Christ Hospital Cancer Center; 🇺🇸 Cincinnati, Ohio, United States

Ohio State University Hospital; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania, Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburg, Pennsylvania, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States