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Monoclonal Antibodies

JANX008 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by Janux Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressed or was intolerant to all available therapies known to confer clinical benefit appropriate for the tumor type
Subjects ≥18 years of age at the time of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug for advanced cancer expressing EGFR.

Who is the study for?
Adults with advanced or metastatic cancers (like lung, kidney, colorectal, or oral cancers) that have progressed despite treatment can join. They must be over 18, have at least one measurable tumor lesion and good organ function. Those who've had certain heart diseases, infections, oxygen therapy, recent cancer treatments or specific prior therapies are excluded.Check my eligibility
What is being tested?
The trial is testing JANX008's safety and effectiveness in treating various advanced cancers expressing a protein called EGFR. It's the first time this drug is being tried in humans to see how it affects tumors and what the body does with it.See study design
What are the potential side effects?
Since this is a first-in-human study for JANX008, potential side effects aren't fully known yet but may include typical reactions to cancer drugs such as fatigue, nausea, inflammation issues and possibly immune system responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not respond or I couldn't tolerate all treatments known to help my type of tumor.
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I am 18 years old or older.
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My cancer is confirmed to be advanced or has spread, including lung, head and neck, colon, or kidney cancer.
Select...
My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Incidence of Clinically Significant Laboratory Abnormalities
Incidence of Dose Limiting Toxicities (DLT)
Secondary outcome measures
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Correlation of EGFR expression level with anti-tumor activity and safety
Duration of Response
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: ExpansionExperimental Treatment1 Intervention
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
Group II: Dose EscalationExperimental Treatment1 Intervention
Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
Group III: Backfill ExpansionExperimental Treatment1 Intervention
Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.

Find a Location

Who is running the clinical trial?

Janux TherapeuticsLead Sponsor
1 Previous Clinical Trials
105 Total Patients Enrolled
Janux Therapeutics, MDStudy DirectorJanux Therapeutics
1 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

JANX008 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05783622 — Phase 1
Colorectal Cancer Research Study Groups: Dose Escalation, Backfill Expansion, Expansion
Colorectal Cancer Clinical Trial 2023: JANX008 Highlights & Side Effects. Trial Name: NCT05783622 — Phase 1
JANX008 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05783622 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential trial participants satisfy?

"This clinical trial is enrolling up to 130 qualified patients, aged 18-100, who have a diagnosis of kidney cancer."

Answered by AI

Has the FDA sanctioned Dose Escalation for clinical use?

"Taking into account the limited clinical data associated with Dose Escalation, our team gave it an overall safety rating of 1."

Answered by AI

Are there any open vacancies for this examination?

"Affirmative. Clinicaltrials.gov records reveal that this research is actively in search of trial participants, with the original posting taking place on March 1st 2023 and most recent editing occurring 29 days later."

Answered by AI

What is the scope of participation in this clinical trial?

"Affirmative, clinicaltrials.gov indicates that this study is currently looking for participants. It was made available on March 1st 2023 and the most recent update was issued on March 29th 2023. 130 patients are expected to join from one location."

Answered by AI

Are individuals of mature age eligible for this clinical trial?

"To qualify for this clinical study, participants must be between 18 and 100 years of age. Separately, there are 125 trials which encompass minors, as well as 4147 studies available to seniors."

Answered by AI
~85 spots leftby Jan 2026