Immunotherapy company Jounce Therapeutics has begun patient enrolment in the Phase II portion of its Phase I/II ICONIC trial of JTX-2011 for the treatment of advanced solid tumours.
JTX-2011 is a monoclonal antibody designed to target ICOS protein present on the surface of specific T-cells in multiple solid tumours.
The two-part Phase II portion of the trial will assess the preliminary efficacy of the product in monotherapy and combination therapy settings.
Patients are currently being recruited for Part C, which will examine JTX-2011 as a monotherapy for solid tumour subjects in three cohorts, including head and neck squamous cell cancer (HNSCC) and non-small-cell lung cancer (NSCLC) patients.
The patients will also be divided based on the levels of ICOS-expressing T-cells in their tumours.
Part D of the trial will evaluate the combination of JTX-2011 with nivolumab across five cohorts, including patients with HNSCC, NSCLC, triple negative breast cancer, melanoma and gastric cancer.
This part is expected to begin enrolling patients in the second quarter of this year.
Jounce Therapeutics chief medical officer Elizabeth Trehu said: “After successfully enrolling and generating data from the Phase I portion of the study, which will be presented at ASCO, our team is enthusiastic about starting the Phase II portion of our ICONIC trial in patients with advanced solid tumours."
The open label, dose-escalation and expansion ICONIC trial includes four parts and two portions.
The Parts A and B of the trial's Phase I portion will evaluate the safety, pharmacokinetics and pharmacodynamics of both the monotherapy and combination therapy.