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

NCT05581719 | Terminated Phase 1

• 1 other identifier: ENX-CL-04-002a
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 6

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.

Conditions

Solid Tumor; Peritoneal Metastases; Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall Response Rate (ORR)/Best Overall Response Rate (BORR)

  12 months

• Clinical benefit rate (CBR)

  12 months

• Duration of response (DoR)

  12 months

• Time to response (TTR)

  12 months

• Progression-free survival (PFS)

  12 months

Study Arms (3)

Stage 1 (Allocetra-OTS monotherapy)

EXPERIMENTAL

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration.

Drug: Allocetra-OTS

Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)

EXPERIMENTAL

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV nivolumab 240 mg.

Drug: Allocetra-OTS; Drug: Nivolumab

Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)

EXPERIMENTAL

Dose escalation of Allocetra-OTS up to 10 x 10\^9 cells by IV or IP administration, with IV tislelizumab 200 mg.

Drug: Allocetra-OTS; Drug: Tislelizumab

Interventions

Allocetra-OTS DRUG

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.

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)

Nivolumab DRUG

Immune checkpoint inhibitor (anti-PD-1 antibody)

Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)

Tislelizumab DRUG

Immune checkpoint inhibitor (anti-PD-1 antibody)

Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enlivex Therapeutics RDO Ltd.: lead

Study Sites (6)

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Clínica Universidad de Navarra

Madrid, Spain

Location

NEXT Madrid

Madrid, Spain

Location

MeSH Terms

Interventions

Nivolumab; tislelizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Roni Shapira, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: November 15, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

ES (2); IL (4)