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Study of JANX008 for Advanced Solid Tumors

This study is testing a new treatment called JANX008 for people with advanced or metastatic (spread) solid tumors, including non-small cell lung cancer, renal cell carcinoma (kidney cancer), and colorectal carcinoma (colon cancer). You may be able to join if your cancer has EGFR (Epidermal Growth Factor Receptor) and has progressed or you could not tolerate other treatments. This is the first time JANX008 is being given to people. Researchers want to understand how safe JANX008 is, what side effects it might cause, and if it shows any early signs of shrinking tumors. The study will also look at how your body handles the drug. About 130 people are expected to join this study.

Study design
This is a Phase 1/1b, open-label study, meaning both you and your doctors will know you are receiving JANX008. It is a multicenter study, involving several locations, and aims to enroll about 130 participants.
What's involved
JANX008 is given through an IV (into a vein) once a week in cycles that last 21 days. The study will monitor for side effects and laboratory changes for up to 4 years.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects and laboratory changes for up to 4 years after you start the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05783622

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Janux Therapeutics
~130 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:JANX008

At a glance

Recruiting sites
0 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLT)
Measured over 21 days
+2 more outcomes measured

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

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Colorectal CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaLung Small Cell CarcinomaPancreatic Ductal AdenocarcinomaRenal Cell CarcinomaSolid NeoplasmTriple-Negative Breast Carcinoma

Where it's being run

18 sites across 12 states
California3
Michigan2
Ohio2
Pennsylvania2
Texas2
Georgia1
Illinois1
Missouri1

Study leadership

  • Janux Therapeutics, MD · STUDY_DIRECTOR · Janux Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 AbnormalitiesUp to 4 years