Clinical trial NCT05581719: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Peritoneal Metastases
Peritoneal Cancer
Lead sponsor: Enlivex Therapeutics RDO Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Allocetra-OTS
timeFrame: 3-5 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)/Best Overall Response Rate (BORR)
timeFrame: 12 months
measure: Clinical benefit rate (CBR)
timeFrame: 12 months
measure: Duration of response (DoR)
timeFrame: 12 months
measure: Time to response (TTR)
timeFrame: 12 months
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: NEXT Madrid
Study officials:
affiliation: Sheba Medical Center
name: Roni Shapira, MD
role: PRINCIPAL_INVESTIGATOR
References: