Oncomatryx Biopharma S.L.
Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.
The study consists of 2 parts: * Part 1: Phase 1 dose-escalation with two parallel staggered escalation cohorts: one cohort of patients treated with OMTX705 as monotherapy and one cohort of patients receiving escalating doses of OMTX705 in combination with standard pembrolizumab. The combination arm will start once OMTX705 monotherapy safety has been evaluated. * Part 2: Five cohorts expansions have been projected to confirm the safety of OMTX705 as monotherapy (SCHED1, SARC1 and BIOPSY) and in combination with tislelizumab (PDAC\_Low and PDAC\_High) will provide additional efficacy and safet…
Inclusion Criteria: 1. Male and female patients aged 18 years and older. 2. Part 1 monotherapy and combination: Patients with histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, or are intolerant to these therapies with any of the following selected tumor histologies: PDAC, gastric cancer (including gastroesophageal junction tumors), head and neck squamous-cell carcinoma (HNSCC), esophageal cancer, NSCLC, high grade serous ovarian cancer, primary perit…
The investigational product is OMTX705 administered as monotherapy at different escalation doses.
Pembrolizumab at 200 mg administered in combination with different escalation doses of OMTX705.
The investigational product is OMTX705 administered as monotherapy at 10 mg/kg
The investigational product is OMTX705 administered as monotherapy at 15 mg/kg
The investigational product is OMTX705 administered as monotherapy at 7.5 mg/kg
Tislelizumab at 200 mg is administered in combination with OMTX705
The investigational product is OMTX administered at 4.0 mg/kg