An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies

Trial Details

Sponsor: Janux Therapeutics (industry)

Phase: 1

Start date: April 19, 2023

Planned enrollment: 130

Trial ID: NCT05783622

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More trial details at ClinicalTrials.gov

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Investigational Drug AI Analysis

Show for: JANX008 (EGFR-TRACTr, EGFRxCD3-TRACTr)

HealthScout AI Analysis

Goal: To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX008 in patients with advanced or metastatic solid tumors expressing EGFR.

Patients: Adults with histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer (CRC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), pancreatic ductal adenocarcinoma (PDAC), or triple-negative breast cancer (TNBC) that have progressed on or were intolerant to prior standard therapies; must have measurable disease per RECIST 1.1 and adequate organ function.

Design: This is a non-randomized, open-label, multicenter Phase 1/1b trial using a dose escalation and dose expansion design. Eligible patients are assigned to escalating dose cohorts, backfill at tolerated dose levels, or expansion at the recommended Phase 2 dose.

Treatments: The investigational therapy studied is JANX008, a bispecific antibody targeting EGFR on tumor cells and CD3 on T cells, built on the TRACTr platform. JANX008 is masked with protease-cleavable domains that inhibit binding until it reaches the tumor microenvironment, reducing off-tumor toxicity. Early data from the ongoing study have shown encouraging safety and anti-tumor activity, with one NSCLC patient achieving a confirmed partial response and good tolerability; most adverse events have been grade 1-2 and primarily in the first cycle.

Outcomes: Primary outcomes include incidence of dose limiting toxicities, adverse events, serious adverse events, and laboratory abnormalities. Secondary endpoints include pharmacokinetic parameters (AUC, Cmax), immunogenicity (anti-drug antibodies), objective response rate, duration of response, progression-free survival, and correlation of EGFR expression with efficacy and safety.

Burden on patient: Patients will experience a high burden due to the Phase 1 nature of the trial, including frequent clinic visits for weekly dosing, intensive pharmacokinetic sampling, and close safety monitoring especially during cycle one. Additional laboratory tests, imaging per RECIST, and possible biopsies for pharmacodynamic assessment may be required. This is typical for first-in-human studies evaluating safety and pharmacological endpoints.

Eligibility

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