Peritoneal Cancer, Peritoneal Metastases, Solid Tumor
Conditions
Brief summary
This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.
Detailed description
Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure. Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2). Allocetra-OTS will be administered systemically or locally (intravenous \[IV\] or intraperitoneal \[IP\]) according to the tumor location.
Interventions
DRUGAllocetra-OTS
Allocetra-OTS is a cell-based therapy consisting of non-HLA matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state.
DRUGNivolumab
Immune checkpoint inhibitor (anti-PD-1 antibody)
DRUGTislelizumab
Immune checkpoint inhibitor (anti-PD-1 antibody)
Sponsors
Enlivex Therapeutics RDO Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients must have measurable disease. 3. Age ≥ 18 years old. 4. ECOG performance status ≤1. 5. Adequate renal function, hepatic function, and bone marrow function.
Exclusion criteria
1. Primary central nervous system (CNS) malignancy or CNS involvement, unless stable clinically. 2. Clinically significant uncontrolled infection, autoimmune or inflammatory diseases requiring systemic immunosuppression, clinically significant cardiovascular disease, severe pulmonary diseases or additional malignancies. 3. \[For patients in Stage 2\] Patients who previously experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Allocetra-OTS | 3-5 weeks | Characterize the safety of Allocetra-OTS based on the dose-limiting toxicities (DLTs) of Allocetra-OTS as monotherapy or in combination with anti-PD1 therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit rate (CBR) | 12 months | Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease \[SD\]). |
| Duration of response (DoR) | 12 months | Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death. |
| Overall Response Rate (ORR)/Best Overall Response Rate (BORR) | 12 months | Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response \[CR\] or partial response \[PR\]). |
| Progression-free survival (PFS) | 12 months | Progression-free survival (PFS), defined as the time to disease progression or death due to any cause. |
| Overall survival (OS) | 12 months | Overall survival (OS) defined as the time to death due to any cause. |
| Time to response (TTR) | 12 months | Time to response (TTR), defined as the time to the first documented CR or PR. |
Countries
Israel, Spain
Outcome results
None listed