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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

Primary Purpose

Solid Tumor, Peritoneal Metastases, Peritoneal Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Allocetra-OTS
Nivolumab
Tislelizumab
Sponsored by
Enlivex Therapeutics RDO Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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]).
Clinical benefit rate (CBR)
Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD]).
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.
Time to response (TTR)
Time to response (TTR), defined as the time to the first documented CR or PR.
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time to disease progression or death due to any cause.
Overall survival (OS)
Overall survival (OS) defined as the time to death due to any cause.

Full Information

First Posted
October 12, 2022
Last Updated
June 19, 2023
Sponsor
Enlivex Therapeutics RDO Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05581719
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enlivex Therapeutics RDO Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Peritoneal Metastases, Peritoneal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 (Allocetra-OTS monotherapy)
Arm Type
Experimental
Arm Description
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration.
Arm Title
Stage 2.1 (Allocetra-OTS in combination with anti-PD-1 therapy)
Arm Type
Experimental
Arm Description
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV nivolumab 240 mg.
Arm Title
Stage 2.2 (Allocetra-OTS in combination with anti-PD-1 therapy)
Arm Type
Experimental
Arm Description
Dose escalation of Allocetra-OTS up to 10 x 10^9 cells by IV or IP administration, with IV tislelizumab 200 mg.
Intervention Type
Drug
Intervention Name(s)
Allocetra-OTS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Immune checkpoint inhibitor (anti-PD-1 antibody)
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Immune checkpoint inhibitor (anti-PD-1 antibody)
Primary Outcome Measure Information:
Title
Safety of Allocetra-OTS
Description
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.
Time Frame
3-5 weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)/Best Overall Response Rate (BORR)
Description
Overall Response Rate (ORR)/Best Overall Response Rate (BORR) (percentage of patients who achieve best response of complete response [CR] or partial response [PR]).
Time Frame
12 months
Title
Clinical benefit rate (CBR)
Description
Clinical benefit rate (CBR) (percentage of patients who achieve best response of CR, PR or stable disease [SD]).
Time Frame
12 months
Title
Duration of response (DoR)
Description
Duration of response (DoR), defined as the time from first documented evidence of CR or PR until disease progression or death.
Time Frame
12 months
Title
Time to response (TTR)
Description
Time to response (TTR), defined as the time to the first documented CR or PR.
Time Frame
12 months
Title
Progression-free survival (PFS)
Description
Progression-free survival (PFS), defined as the time to disease progression or death due to any cause.
Time Frame
12 months
Title
Overall survival (OS)
Description
Overall survival (OS) defined as the time to death due to any cause.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lior Binder
Phone
+972548054899
Email
lior@enlivexpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roni Shapira, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Perets, MD
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aron Popovtzer, MD
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roni Shapira, MD
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravit Geva, MD
Facility Name
Clínica Universidad de Navarra
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano Ponz Sarvisé, MD
Facility Name
NEXT Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Boni, MD

12. IPD Sharing Statement

Learn more about this trial

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

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