A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
Solid Tumor, Peritoneal Metastases, Peritoneal Cancer
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors, that have relapsed or have been refractory to available approved therapies, or patients who are not eligible for or declined additional standard of care systemic therapy.
Patients with peritoneal carcinomatosis can be eligible if an appropriate IP catheter or port can be placed.
- Patients must have measurable disease.
- Age ≥ 18 years old.
- ECOG performance status ≤1.
- Adequate renal function, hepatic function, and bone marrow function.
Exclusion Criteria:
- Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically.
- Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies.
- [For patients in Stage 2] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
Sites / Locations
- Rambam Medical CenterRecruiting
- Hadassah Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- Sourasky Medical CenterRecruiting
- Clínica Universidad de NavarraRecruiting
- NEXT MadridRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Stage 1 (Allocetra-OTS monotherapy)
Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)
Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration.
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg.
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg.