Study Of JANX008 In Subjects With Advanced Or Metastatic Solid Tumor Malignancies

Study Overview

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.

N/A

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

DRUG: JANX008

EGFR-008-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-03-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-11
First Submitted that Met QC Criteria 2023-03-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-14
First Posted (ACTUAL) 2023-03-24	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.	DRUG: JANX008 JANX008 is dosed via IV weekly in a 21-day cycle
EXPERIMENTAL: Backfill Expansion Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.	DRUG: JANX008 JANX008 is dosed via IV weekly in a 21-day cycle
EXPERIMENTAL: Expansion Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).	DRUG: JANX008 JANX008 is dosed via IV weekly in a 21-day cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dose Escalation

Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.

DRUG: JANX008

JANX008 is dosed via IV weekly in a 21-day cycle

EXPERIMENTAL: Backfill Expansion

Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.

DRUG: JANX008

JANX008 is dosed via IV weekly in a 21-day cycle

EXPERIMENTAL: Expansion

Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).

DRUG: JANX008

JANX008 is dosed via IV weekly in a 21-day cycle

Primary Outcome Measures	Measure Description	Time Frame
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 Abnormalities		Up to 4 years

Secondary Outcome Measures	Measure Description	Time Frame
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)		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)		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		Up to 4 years
Overall Response Rate	Proportion of participants who achieve a complete response or partial response per RECIST v1.1	Up to 4 years
Duration of Response	Time from documentation of CR or PR to disease progression per RECIST v1.1	Up to 4 years
Progression Free Survival	Time from treatment initiation to disease progression per RECIST v1.1	Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety		Up to 4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Janux Therapeutics

Phone Number: 858-206-8471

Email: EGFR-008-001_ct.gov@januxrx.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Janux Therapeutics, MD, Janux Therapeutics

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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