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New hope for advanced cancers: JANX008 enters human testing

NCT ID NCT05783622

Disease control Sponsor: Janux Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called JANX008 in about 130 adults with advanced solid tumors, including lung, kidney, head and neck, colorectal, pancreatic, and breast cancers. The main goal is to check safety and find the right dose. Participants must have tried all standard treatments without success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal carcinoma colorectal neoplasm head and neck squamous cell carcinoma non-small cell lung carcinoma pancreatic ductal adenocarcinoma renal cell carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal carcinoma Non-small cell lung cancer Pancreatic ductal adenocarcinoma Renal cell carcinoma Small cell lung cancer Squamous cell carcinoma of the head and neck Triple-negative breast cancer

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Laura and Isaac Perlmutter Cancer Center NYU Langone Health

    New York, New York, 10016, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219, United States

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California San Diego Moores Cancer Center

    San Diego, California, 92093, United States

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30308, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.