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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
Must not have
On supplemental oxygen
Prior treatment with EGFR-targeted bispecific T cell engager or CAR-T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use supplemental oxygen.
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I have previously received EGFR-targeted immune therapy.
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I have been treated with CD3 bispecific antibodies before.
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I do not have any serious infections.
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I have a serious heart condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of Response
Overall Response Rate
Progression Free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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: Expansion, Dose Escalation, Backfill 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
~49 spots leftby Jan 2026
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