JSI-1187 / JS InnoPharm - LARVOL DELTA

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov) - P1 | N=71 | Suspended | Sponsor: JS InnoPharm, LLC | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor • Thyroid Gland Carcinoma • MAP2K1 • NF1 • RASA1

Phase 1 study of ERK inhibitor JSI-1187 for patients with advanced solid tumors with MAPK pathway mutations. (ASCO 2024) - P1 | "JSI-1187 monotherapy is well-tolerated in advanced solid tumor patients and demonstrated preliminary antitumor effect. Current evidence supports future exploration of JSI-1187 as monotherapy, and in combination, in patients with MAPK-mutant tumors. Research Sponsor: JS Innopharm Clinical trial information: NCT06239623."

Clinical • Metastases • P1 data • Anemia • Hematological Disorders • Infectious Disease • Leukopenia • Lung Cancer • Macular Edema • Melanoma • Neutropenia • Oncology • Ophthalmology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombocytopenia • BRAF • MAP2K1 • NRAS

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov) - P1 | N=71 | Suspended | Sponsor: JS InnoPharm, LLC | N=124 ➔ 71 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial primary completion date • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • MAP2K1 • NF1 • RASA1

ERK Inhibitor JSI-1187 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: JS InnoPharm, LLC

New P1 trial • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov) - P1 | N=124 | Suspended | Sponsor: JS InnoPharm, LLC | Recruiting ➔ Suspended | Trial primary completion date: May 2023 ➔ Dec 2023

Combination therapy • Metastases • Monotherapy • Trial primary completion date • Trial suspension • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • MAP2K1 • NF1 • RASA1

Efficacy of JSI-1187 or VIC-1911 in combination with KRAS G12C inhibitors for the treatment of KRAS G12C-mutated non-small cell lung cancer and colorectal cancer (AACR 2023) - "JSI-1187 or VIC-1911 combined with sotorasib or adagrasib demonstrated marked enhancement of the antitumor effect compared with single-agent treatment in a H2122 mouse xenograft model. Additionally, the antitumor growth effect of JSI-1187 and sotorasib was significantly better than the combination of the MEK inhibitor, trametinib, and sotorasib...In addition, the combination of JSI-1187 and sotorasib demonstrated a significant increase in tumor growth inhibition in a CRC PDX model. Taken together, our preclinical studies suggest that the combination of an ERK inhibitor, JSI-1187, or an AURKA inhibitor, VIC-1911, may potentially overcome the primary resistance and prevent or delay the acquired resistance to G12C inhibitors."

Clinical • Combination therapy • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: JS InnoPharm, LLC | Trial completion date: Nov 2023 ➔ Nov 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • MAP2K1 • NF1 • RASA1

JS InnoPharm Initiates Treatment With JSI-1187, a Selective ERK Inhibitor, in Combination With Dabrafenib for Advanced Solid Tumors With BRAF V600E/K mutations (Businesswire) - "JS InnoPharm Ltd initiated the JSI-1187 plus dabrafenib combination dose-escalation phase of the Phase 1 study for patients with locally advanced or metastatic solid tumors with confirmed BRAF V600E/K mutations (NCT04418167). The clinical study is being conducted at 8 NCI-designated Comprehensive Cancer Centers in the U.S."

Trial status • Oncology • Solid Tumor • BRAF

[VIRTUAL] The ERK1/2 inhibitor, JSI-1187, demonstrates preclinical efficacy in tumor models with MAPK pathway mutations (AACR-II 2020) - "JSI-1187 and dabrafenib demonstrated synergistic efficacy in tumor growth inhibition. In conclusion, JSI-1187 can be potentially used for treatment of cancer with MAPK pathway mutations."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • BRAF • EGFR • KRAS • MAPK1

JS InnoPharm Announces First Patient Dosed with JSI-1187, a Selective ERK Inhibitor, in Phase 1 Clinical Study for Advanced Solid Tumors with MAPK Pathway Mutations (Businesswire) - "JS InnoPharm Ltd today announced the enrollment of the first patient in a Phase 1, open-label, monotherapy dose-escalation and expansion study of JSI-1187, the company’s lead investigational drug candidate targeting the enzymes ERK1 and ERK2....The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of JSI-1187 in patients with relapsed, refractory solid tumors with MAPK mutations."

Enrollment open • Oncology • Solid Tumor

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov) - P1; N=121; Recruiting; Sponsor: JS InnoPharm, LLC

Combination therapy • Monotherapy • New P1 trial • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • MAP2K1