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

• ClinicalTrials.gov Identifier: NCT05783622
• Recruitment Status: Recruiting
• First Posted: March 24, 2023
• Last Update Posted: April 22, 2024
• Sponsor: Janux Therapeutics
• Information provided by (Responsible Party): Janux Therapeutics

Tracking Information

• First Submitted Date: March 14, 2023
• First Posted Date: March 24, 2023
• Last Update Posted Date: April 22, 2024
• Actual Study Start Date: April 19, 2023
• Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2023)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 14, 2023)

• 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 ]
  Proportion of participants who achieve a complete response or partial response per RECIST v1.1
• Duration of Response [ Time Frame: Up to 4 years ]
  Time from documentation of CR or PR to disease progression per RECIST v1.1
• Progression Free Survival [ Time Frame: Up to 4 years ]
  Time from treatment initiation to disease progression per RECIST v1.1
• Correlation of EGFR expression level with anti-tumor activity and safety [ Time Frame: Up to 4 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
• Official Title: An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Non-Small Cell Lung Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of the Head and Neck
• Colorectal Carcinoma

Intervention

Drug: JANX008

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

Study Arms

• Experimental: Dose Escalation
  Subjects will be dosed weekly during each 21-day cycle. Dosage per cohort will increase to determine the maximum tolerable dose.
  Intervention: Drug: JANX008
• Experimental: Backfill Expansion
  Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at levels previously declared tolerable.
  Intervention: Drug: JANX008
• Experimental: Expansion
  Subjects will be dosed weekly during each 21-day cycle. Subjects will be dosed at the preliminary recommended Phase 2 dose (RP2D).
  Intervention: Drug: JANX008

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 14, 2023): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2027
• Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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, or RCC
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Janux Therapeutics; 858-751-4493; EGFR-008-001_ct.gov@januxrx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05783622
• Other Study ID Numbers: EGFR-008-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Janux Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Janux Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Janux Therapeutics, MD; Janux Therapeutics

• PRS Account: Janux Therapeutics
• Verification Date: February 2024