LNP3794 / Boehringer Ingelheim, Lupin - LARVOL DELTA

A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Lupin Ltd. | Active, not recruiting ➔ Completed

Metastases • Trial completion • Oncology • Solid Tumor • KRAS • NRAS

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]) (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Boehringer Ingelheim | Completed ➔ Terminated; Sponsor decision

Combination therapy • Metastases • Monotherapy • Preclinical • Trial termination • Oncology • Sarcoma • Solid Tumor • KRAS

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]) (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Boehringer Ingelheim | Terminated ➔ Completed

Trial completion • Oncology • Sarcoma • Solid Tumor • KRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Oct 2022

Trial completion • Trial completion date • Oncology • Solid Tumor • KRAS • NRAS

MEKi-based combination strategies for targeting KRAS-driven cancer (AACR-NCI-EORTC 2022) - "We also combine BI 3011441 with BI 1701963 and BI 894999 - two potent, selective, and orally bioavailable inhibitors of SOS1 and BET, respectively. In summary, we show that combining BI 3011441 with SOS1 or BET inhibitors may lead to improved responses in KRAS mutant tumors, likely by circumventing MAPK pathway-related adaptive resistance."

Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • BRAF • KRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • KRAS • NRAS

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]) (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Boehringer Ingelheim | N=124 ➔ 8 | Trial completion date: Jul 2024 ➔ Apr 2022 | Suspended ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Apr 2022; Sponsor decision

Combination therapy • Enrollment change • Monotherapy • Preclinical • Trial completion date • Trial primary completion date • Trial termination • Oncology • Sarcoma • Solid Tumor • KRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • KRAS • NRAS

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]) (clinicaltrials.gov) - P1 | N=124 | Suspended | Sponsor: Boehringer Ingelheim | Recruiting ➔ Suspended

Combination therapy • Monotherapy • Preclinical • Trial suspension • Oncology • Sarcoma • Solid Tumor • KRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor • KRAS • NRAS

A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: Lupin Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor • KRAS • NRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Boehringer Ingelheim; Trial primary completion date: Nov 2021 ➔ Mar 2022

Clinical • Trial primary completion date • Oncology • Solid Tumor • KRAS • NRAS

[VIRTUAL] Trial in Process: Phase 1 studies of BI 1701963, a SOS1::KRAS Inhibitor, in combination with MEK inhibitors, irreversible KRASG12C inhibitors or irinotecan. (AACR 2021) - "Here, we present pre-clinical data showing enhanced pathway modulation and synergistic anti-tumor effects following vertical pathway inhibition of BI 1701963 in combination with mitogen-activated protein kinase inhibitors (MEKi; trametinib and BI 3011441) or KRAS G12C inhibitors (MRTX849 and BI 1823911). Primary endpoints include dose-limiting toxicities, treatment-emergent or -related adverse events. Secondary endpoints include pharmacokinetic and pharmacodynamic properties of combination regimens and preliminary efficacy."

Combination therapy • P1 data • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • KRAS • SOS1

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS]) (clinicaltrials.gov) - P1; N=124; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Sep 2023 ➔ Jul 2024; Trial primary completion date: Nov 2022 ➔ Oct 2023

Clinical • Combination therapy • Monotherapy • Preclinical • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Solid Tumor • KRAS

Lupin receives USD 50 million from Boehringer Ingelheim for achievement of key milestones (Outlookindia.com) - "Drug major Lupin on Thursday said it has received payment of USD 50 million (around Rs 363.5 crore)...In a regulatory filing Lupin announced 'the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers.'"

Commercial • Oncology

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (KRAS) (clinicaltrials.gov) - P1; N=124; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor • KRAS

Boehringer Ingelheim and MD Anderson Expand Collaboration to Accelerate Development of KRAS and TRAILR2 Compounds in Lung Cancer (Businesswire) - "Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center...announced the extension and expansion of their joint Virtual Research and Development Center (VRDC) to explore new molecules from Boehringer Ingelheim’s KRAS (Kirsten rat sarcoma) and TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) portfolios for the potential treatment of lung cancer, particularly non-small cell lung cancer....The flexible nature of the VRDC agreement allows the teams to expand their lung cancer indication programs targeting KRAS and TRAILR2, including Boehringer Ingelheim’s first-in-class SOS1::pan-KRAS inhibitor (BI 1701963), inhibitors of KRAS G12C (BI 1823911) and MEK (BI 3011441), as well as a novel undisclosed bi-specific TRAILR2 agonist."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (KRAS) (clinicaltrials.gov) - P1; N=124; Not yet recruiting; Sponsor: Boehringer Ingelheim

New P1 trial • Oncology • Solid Tumor • KRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial • Oncology • Solid Tumor • KRAS • NRAS

A Study to Test Different Doses of BI 3011441 in Japanese People With Different Types of Advanced Cancer (NRAS/KRAS Mutation Positive) (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor • KRAS • NRAS