Non-Small Cell Lung CancerPhase 1NCT05783622
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
A Phase 1 study testing JANX008 in people with Non-Small Cell Lung Cancer and Renal Cell Carcinoma, run by Janux Therapeutics at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- JANX008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 18 sitesUnited States
- Study dates
- 19 Apr 2023to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Michigan
Ann Arbor, Michigan, 48109
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30308
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219
Ohio State University Hospital
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope Medical Center
Duarte, California, 91010
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Laura and Isaac Perlmutter Cancer Center NYU Langone Health
New York, New York, 10016
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Rhode Island Hospital
Providence, Rhode Island, 02903
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of California San Diego Moores Cancer Center
San Diego, California, 92093
Washington University
St Louis, Missouri, 63110
About this study
Official title: An Open-Label, Multicenter, Phase 1/1b 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.
- 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
- Being tested
- JANX008
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JANX008Drug
JANX008 is dosed via IV weekly in a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose. Receives: Drug: JANX008 |
| Backfill Expansion | Experimental | Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable. Receives: Drug: JANX008 |
| Expansion | Experimental | Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D). Receives: Drug: JANX008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLT)
Measured: 21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Measured: Up to 4 years
Secondary outcomes (7)
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Measured: 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)
Maximum observed concentration of JANX008 (Cmax)
Measured: 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)
Number of participants who develop anti-drug antibodies against JANX008
Measured: Up to 4 years
Overall Response Rate
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Measured: Up to 4 years
Duration of Response
Time from documentation of CR or PR to disease progression per RECIST v1.1
Measured: Up to 4 years
Progression Free Survival
Time from treatment initiation to disease progression per RECIST v1.1
Measured: Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start19 Apr 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janux Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janux Therapeutics, MD, Study director, Janux Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783622
- Sponsor's protocol ID
- EGFR-008-001
- Status last verified
- May 2026
- First submitted
- 14 Mar 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05783622
- Acronym / sponsor ID
- EGFR-008-001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Janux TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JANX008Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose. |
| Backfill Expansion | Experimental | Drug: JANX008Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable. |
| Expansion | Experimental | Drug: JANX008Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JANX008JANX008 is dosed via IV weekly in a 21-day cycle | Drug | Backfill Expansion, Dose Escalation, Expansion |
Primary outcome
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Time frame: Up to 4 years
7 secondary outcomes
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)
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)
Number of participants who develop anti-drug antibodies against JANX008
Time frame: Up to 4 years
Overall Response Rate
Time frame: Up to 4 years
Duration of Response
Time frame: Up to 4 years
Progression Free Survival
Time frame: Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janux Therapeutics, MD study director
Janux Therapeutics
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JANX008 in people with Non-Small Cell Lung Cancer and Renal Cell Carcinoma, run by Janux Therapeutics at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLT) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.