Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

Janux Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Colorectal Carcinoma; Squamous Cell Carcinoma of the Head and Neck; Small Cell Lung Cancer; Triple-negative Breast Cancer; Pancreatic Ductal Adenocarcinoma; Renal Cell Carcinoma; Non-Small Cell Lung Cancer

Treatments: Drug: JANX008

Study type: Interventional

Funder types: Industry

Identifiers

NCT05783622

EGFR-008-001

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: JANX008

Backfill Expansion

Experimental group

Description:

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

Treatment:

Drug: JANX008

Expansion

Experimental group

Description:

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

Treatment:

Drug: JANX008