A first-in-human, open-label, dose-escalation trial is underway to assess the safety and preliminary efficacy of GEN1055, a novel antibody, in patients with advanced solid tumors. The Phase 1 trial (GCT1055-01) is designed to evaluate GEN1055 as a monotherapy and in combination with pembrolizumab, with or without chemotherapy.
The trial consists of two parts: a dose-escalation phase to determine the safety and optimal dosage of GEN1055, followed by an expansion cohort to further evaluate the efficacy of the selected doses. Patients will be treated with GEN1055 alone, GEN1055 with pembrolizumab, or GEN1055 with pembrolizumab and chemotherapy. The treatment duration can last up to 24 months for pembrolizumab-containing regimens, contingent on disease progression, adverse events, or the patient's/physician's decision to discontinue.
Participants will undergo weekly visits for the first 12 weeks, followed by visits every three weeks thereafter. These visits will include blood draws, electrocardiograms, and computed tomography (CT) scans to monitor treatment safety and efficacy. The total trial duration for each participant, including screening, treatment, and follow-up, is approximately 39 months.
The study's primary objective is to assess the safety and tolerability of GEN1055. Secondary objectives include evaluating the preliminary efficacy of GEN1055 in terms of objective response rate, duration of response, and progression-free survival. The trial is currently enrolling patients at multiple sites.
