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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05581719
• Other study ID #: ENX-CL-04-002a
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 15, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Enlivex Therapeutics RDO Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Peritoneal Cancer
• Peritoneal Metastases
• Solid Tumor

Intervention

Drug:
• Allocetra-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.
• Nivolumab
Immune checkpoint inhibitor (anti-PD-1 antibody)
• Tislelizumab
Immune checkpoint inhibitor (anti-PD-1 antibody)

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Israel	Sourasky Medical Center	Tel Aviv
Spain	Clínica Universidad de Navarra	Madrid
Spain	NEXT Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Enlivex Therapeutics RDO Ltd.

Countries where clinical trial is conducted

Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Allocetra-OTS	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.	3-5 weeks
Secondary	Overall Response Rate (ORR)/Best Overall Response Rate (BORR)	Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response [CR] or partial response [PR]).	12 months
Secondary	Clinical benefit rate (CBR)	Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD]).	12 months
Secondary	Duration of response (DoR)	Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death.	12 months
Secondary	Time to response (TTR)	Time to response (TTR), defined as the time to the first documented CR or PR.	12 months
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS), defined as the time to disease progression or death due to any cause.	12 months
Secondary	Overall survival (OS)	Overall survival (OS) defined as the time to death due to any cause.	12 months