Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Carcinoma

Lung Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients with advanced solid tumors. Up to 3 dose levels evaluated.

Patients with advanced urothelial/bladder cancer.

APR-246 (eprenetapopt) + Pembrolizumab

Joachim Gullbo, MD

A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

This is a phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 (eprenetapopt) in combination with pembrolizumab in subjects with solid tumor malignancies. In the safety lead-in part of study (phase 1), the safety and the recommended phase 2 dose (RP2D) of APR-246 will be investigated.

In the expansion part of the study (phase 2), both safety and efficacy for the combination therapy will be investigated in the 3 cohorts.

Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

To determine the occurrence of dose limiting toxicities (DLTs), classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Frequency of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) related to APR-246 in combination with pembrolizumab.

To determine the dose of APR-246 to be selected for the expansion phase based on the occurence of dose limiting toxicities (DLTs) experienced during the safety assessment period

Aprea Therapeutics

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Antirheumatic Agents

Amino Acids

Venetoclax

Acalabrutinib

Rituximab

Immunologic Factors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

APR-246 + Acalabrutinib in Subjects with R/R CLL.

APR-246 + Venetoclax + Rituximab in Subjects with R/R CLL.

APR-246 + (Acalabrutinib, OR, (Ven+R)) in Subjects with R/R TP53-mutant CLL, and/or MCL, and/or RT

APR-246 + Venetoclax + Rituximab in Subjects with RT

APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule

APR-246 (eprenetapopt) + Acalabrutinib in CLL

APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule

APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL

APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule Venetoclax and Rituxiab will be given at a standard dose and schedule

APR-246 (eprenetapopt) + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT

APR-246 (eprenetapopt) + Venetoclax + Rituximab in RT

Study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 in combination with either acalabrutinib or venetoclax + rituximab therapy in subjects with NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL.

Phase 1, open-label, dose-finding and cohort expansion study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 (eprenetapopt) in combination with either acalabrutinib or venetoclax + rituximab therapy in subjects with NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL.

The study includes a safety lead-in portion followed by an expansion portion in subjects with R/R CLL, Richter Transformation (RT), and R/R MCL.

APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)

Phase 1 and Dose Expansion Study of APR-246 in Combination With Acalabrutinib or Venetoclax-based Therapy in Subjects With R/R NHL Including Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL)

The occurrence of DLTs, classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events .

The frequency of TEAEs and SAEs related to APR-246 in combination with acalabrutinib and with venetoclax + rituximab therapy

The highest dose of APR-246 with acceptable toxicity (RP2D of APR-246) (the dose producing ≤ 20% of DLT).

Recurrence

Patients receive eprenetapopt IV over 6 hours on days 1-4 and venetoclax PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eprenetapopt

Luhua (Michael) Wang

This phase II trial investigates the effect of venetoclax and eprenetapopt in treating patients with mantle cell lymphoma that has come back (relapsed) or dose not respond to treatment (refractory). Chemotherapy drugs, such as venetoclax and eprenetapopt, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVE:

I. To determine the efficacy (overall response rate) of the eprenetapopt plus venetoclax combination in relapsed refractory mantle cell lymphoma (MCL) patients (with/without TP53 aberrations).

SECONDARY OBJECTIVES:

I. To determine the safety profile of the eprenetapopt plus venetoclax combination in relapsed refractory MCL patients.

II. To evaluate the overall survival and progression-free survival of the eprenetapopt plus venetoclax combination in relapsed refractory MCL patients.

OUTLINE:

Patients receive eprenetapopt intravenously (IV) over 6 hours on days 1-4 and venetoclax orally (PO) once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 5 years, and then annually thereafter.

Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma

An Open Label, Phase II Investigator-Initiated Study of Venetoclax and Eprenetapopt (APR-246) in Previously Treated Relapsed/Refractory Patients With Mantle Cell Lymphoma (MCL)

Will be based on Cheson, Lugano Classification 2014. Its associated exact 95% confidence interval will be presented.

Kaplan-Meier methodology will be utilized.

Will be summarized by providing the median DOR together with associated 95% confidence interval, using Kaplan-Meier methodology.

Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Will be assessed by NCI CTCAE version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies	NCT04383938	Bladder Cancer Gastric Cancer Non Small Cell ... NSCLC Urothelial Carc... Advanced Solid ...	APR-246 (eprene...	18 Years -	Aprea Therapeutics
APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)	NCT04419389	Non Hodgkin Lym... Chronic Lymphoc... Mantle Cell Lym...	APR-246 (eprene... APR-246 (eprene... APR-246 (eprene... APR-246 (eprene...	18 Years -	Aprea Therapeutics
Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma	NCT04990778	Recurrent Mantl... Refractory Mant...	Eprenetapopt Venetoclax	18 Years -	M.D. Anderson Cancer Center
APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)	NCT04419389	Non Hodgkin Lym... Chronic Lymphoc... Mantle Cell Lym...	APR-246 (eprene... APR-246 (eprene... APR-246 (eprene... APR-246 (eprene...	18 Years -	Aprea Therapeutics
Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies	NCT04383938	Bladder Cancer Gastric Cancer Non Small Cell ... NSCLC Urothelial Carc... Advanced Solid ...	APR-246 (eprene...	18 Years -	Aprea Therapeutics

Spots Global Cancer Trial Database for eprenetapopt

Every month we try and update this database with for eprenetapopt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.