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: 2024-02
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
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.
Expansion	JANX008	Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).

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 (13)

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

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, 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