BI 836858 / Boehringer Ingelheim - LARVOL DELTA

Beat AML: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=2000 | Recruiting | Sponsor: Beat AML, LLC | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=49 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Phase I Trial of the Antibody-Cytokine Fusion Protein F16IL2 in Combination with Anti-CD33 Immunotherapy for Posttransplant AML Relapse (ASH 2021) - "In this novel-novel combination dose-escalation phase 1 trial, we enrolled patients with AML relapse after allogeneic hematopoietic stem cell transplantation (HSCT) to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary activity of F16IL2, an antibody-cytokine fusion protein composed of the human antibody fragment scFv(F16) in diabody format and two molecules of human IL-2, in combination with the Fc-optimized, ADCC-mediating anti-CD33 monoclonal antibody BI 836858. In the difficult-to-treat situation of posttransplant AML relapse, responses were observed at higher DL, even in patients with extramedullary disease. The antibody-mediated targeted delivery of IL-2 to the ECM combined with anti-CD33 immunotherapy represents an innovative experimental approach associated with acceptable safety and encouraging biologic and clinical activity in posttransplant AML relapse."

Combination therapy • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Respiratory Diseases • Transplantation • IL2

An open-label, phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858, an unconjugated anti-CD33 monoclonal antibody, in combination with decitabine in patients with acute myeloid leukemia. (PubMed, Haematologica) - "Not available."

Combination therapy • Journal • P1/2 data • PK/PD data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A phase I/II multicenter, open-label, dose escalation and randomized trial of BI 836858 in patients with low or intermediate-1 risk myelodysplastic syndrome. (PubMed, Haematologica) - "Not available."

Journal • P1/2 data • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Using stroma-anchoring cytokines to augment ADCC: a phase 1 trial of F16IL2 and BI 836858 for posttransplant AML relapse. (PubMed, Blood Adv) - "ECM-targeted IL-2 combined with anti-CD33 immunotherapy represents an innovative approach associated with acceptable safety and encouraging biologic and clinical activity in posttransplant AML relapse. This trial was registered at EudraCT (2015-004763-37)."

Journal • P1 data • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Respiratory Diseases • Transplantation • IL2

PHIBI: Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Philogen S.p.A. | Recruiting ➔ Completed | N=52 ➔ 15

Combination therapy • Enrollment change • Trial completion • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Feb 2020 ➔ Dec 2022

Combination therapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Phase classification: P2 ➔ P1/2

Clinical • Combination therapy • Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A phase I study of the fully human, fragment crystallizable-engineered, anti-CD-33 monoclonal antibody BI 836858 in patients with previously-treated acute myeloid leukemia. (PubMed, Haematologica) - "Not available."

Clinical • Journal • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Nov 2021 ➔ Nov 2022; Trial primary completion date: Nov 2021 ➔ Nov 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=2000; Recruiting; Sponsor: Beat AML, LLC; Trial completion date: Dec 2021 ➔ Dec 2023; Trial primary completion date: Dec 2021 ➔ Dec 2023

Biomarker • Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Combination therapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Nov 2020 ➔ Nov 2021

Clinical • Combination therapy • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=25; Terminated; Sponsor: Boehringer Ingelheim; Completed ➔ Terminated

Clinical • Trial termination • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

A phase I dose escalation study of weekly BI 836845, a fully human, affinity-optimized, insulin-like growth factor (IGF) ligand neutralizing antibody, in patients with advanced solid cancers (ASCO 2014) - Presentation time: Sunday, Jun 1; 8:00 AM - 11:45 AM; Abstract #2617; P1, N=48; NCT01403974; Sponsor: Boehringer Ingelheim; "MTD was not reached. BI 836845 showed a dose-proportional PK with a terminal half-life of about 6 days, a volume of distribution of 5.8 L, and a total plasma clearance of 0.5 mL/min"

P1 data • Oncology

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=25; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed; N=200 ➔ 25

Clinical • Enrollment change • Trial completion

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: Boehringer Ingelheim; N=27 ➔ 200; Trial completion date: Dec 2021 ➔ Jan 2020

Clinical • Enrollment change • Trial completion date

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: Nov 2020 ➔ Nov 2019

Clinical • Combination therapy • Trial primary completion date

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: Nov 2019 ➔ Nov 2020

Clinical • Combination therapy • Trial primary completion date

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=27; Active, not recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Active, not recruiting; N=200 ➔ 27

Clinical • Enrollment change • Enrollment closed

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting ➔ Active, not recruiting; N=170 ➔ 49

Clinical • Combination therapy • Enrollment change • Enrollment closed

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2; N=170; Recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: Nov 2020 ➔ Nov 2019

Clinical • Combination therapy • Trial primary completion date

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=200; Suspended; Sponsor: Boehringer Ingelheim; Trial primary completion date: Dec 2021 ➔ Jan 2020

Clinical • Trial primary completion date

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes (clinicaltrials.gov) - P2; N=200; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Clinical • Trial suspension