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NCT Number: NCT05783622

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Ductal Adenocarcinoma Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Head and Neck Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-negative Breast Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope Medical Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JANX008

Drug

JANX008 is dosed via IV weekly in a 21-day cycle

Primary outcomes

  1. Incidence of Dose Limiting Toxicities (DLT)

    Time frame: 21 days

  2. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Time frame: Up to 4 years

  3. Incidence of Clinically Significant Laboratory Abnormalities

    Time frame: Up to 4 years

Secondary outcomes

  1. 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)

  2. 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)

  3. Number of participants who develop anti-drug antibodies against JANX008

    Time frame: Up to 4 years

  4. Overall Response Rate

    Time frame: Up to 4 years

    Proportion of participants who achieve a complete response or partial response per RECIST v1.1

  5. Duration of Response

    Time frame: Up to 4 years

    Time from documentation of CR or PR to disease progression per RECIST v1.1

  6. Progression Free Survival

    Time frame: Up to 4 years

    Time from treatment initiation to disease progression per RECIST v1.1

  7. Correlation of EGFR expression level with anti-tumor activity and safety

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Janux Therapeutics

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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