NMS-153 / Nerviano Medical Sciences - LARVOL DELTA

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=31 | Terminated | Sponsor: Nerviano Medical Sciences | Completed ➔ Terminated; In the Phase II part of the study, among the participants evaluable for efficacy, no objective (partial response or clinical response) was observed at the first futility analysis.

Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=31 | Completed | Sponsor: Nerviano Medical Sciences | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Aug 2024

Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

The MPS1/TTK inhibitor, NMS-01940153, synergizes with tisotumab vedotin in colorectal cancer (AACR 2024) - P1/2 | "Background: MPS1 kinase plays a crucial role in maintaining genomic integrity by controlling the spindle assembly checkpoint (SAC). The combination of NMS-153 with TV is synergistic in the LS411N CRC model. These data strongly suggest the potential for clinical efficacy of NMS-153 with TV and the combinability of NMS-153 with TV and other MMAE-based ADCs in different tumor contexts."

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=31 | Active, not recruiting | Sponsor: Nerviano Medical Sciences | Recruiting ➔ Active, not recruiting | N=57 ➔ 31 | Trial completion date: Mar 2026 ➔ Mar 2025 | Trial primary completion date: Nov 2025 ➔ Jan 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Nerviano Medical Sciences | Trial completion date: Mar 2027 ➔ Mar 2026 | Trial primary completion date: Nov 2026 ➔ Nov 2025

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Phase II study on safety and efficacy of NMS-01940153E, an MPS1 inhibitor with first-in-class potential, in adult patients with unresectable hepatocellular carcinoma (HCC) previously treated with systemic therapy. (ASCO 2023) - P1/2 | "In HCC lines, specifically, NMS-01940153E showed ~2-Log higher anti-proliferative activity compared to sorafenib, lenvatinib, and regorafenib. Recruitment is currently ongoing in Italy and Spain and an FDA “Study May Proceed Notification” was received in January 2023. Clinical trial information: NCT05630937."

Clinical • IO biomarker • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Immune Modulation • Oncology • Solid Tumor

NMS-01940153E, an MPS1 inhibitor with anti-tumor activity in relapsed or refractory unresectable Hepatocellular carcinoma (AACR-NCI-EORTC 2022) - P1/2 | "In HCC lines NMS-01940153E showed ~2-Log higher anti-proliferative activity compared to sorafenib, lenvatinib, and regorafenib. Conclusion NMS-01940153E showed preclinical and clinical activity in HCC with manageable safety features. This MPS1 inhibitor is currently under evaluation in the phase 2 part of the study in patients with unresectable HCC previously treated with standard-of-care systemic therapy."

Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

NMS-01940153E, an MPS1 inhibitor with anti-tumor activity in relapsed or refractory unresectable hepatocellular carcinoma (LCS 2023) - P1/2 | "In the phase 1, a 3+3 escalation design started at 100 mg/m2/wk, to determine MTD and RP2D In HCC lines, NMS-153 showed ~2-Log higher antiproliferative activity compared to sorafenib, lenvatinib, and regorafenib. NMS-153 targets a novel mitotic mechanism and showed preclinical and clinical activity in HCC, including two confirmed PRs. Safety features were reasonable, with manageable and reversible neutropenia as the most frequent any grade TRAE. NMS-153 is currently under evaluation in patients with unresectable HCC previously treated with at least 1 immunotherapy as first line and 1 TKI line"

Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

NMS-01940153E, an MPS1 inhibitor with anti-tumor activity in relapsed or refractory unresectable Hepatocellular carcinoma (AEEH 2023) - No abstract available

Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

NMS-01940153E, an MPS1 inhibitor with antitumor activity in relapsed or refractory unresectable Hepatocellular carcinoma (AEEH 2023) - No abstract available

Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

MPS1 (NMS-01940153E) Kinase Inhibitor Shows Clinical Activity in Primary Liver Cancer - P1 | N=57 | NCT05630937 | Sponsor: Nerviano Medical Sciences | "The targeted drug NMS-01940153E, a monopolar spindle 1 (MPS1) kinase inhibitor, has shown signs of clinical activity in a Phase I study of patients with relapsed or refractory unresectable hepatocellular carcinoma (HCC). The study findings were reported at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics....The study reported that the experimental agent had shown orders of magnitude (two logs) higher anti-proliferative activity in HCC cell lines than sorafenib, lenvatinib, and regorafenib, which are kinase inhibitor drugs already being tried to treat HCC."

P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

"#MPS1 (#NMS01940153E) Kinase Inhibitor Shows Clinical Activity in Primary #LiverCancer https://t.co/eUNEkaRx1n" (@1stOncology)

Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Nerviano Medical Sciences | Initiation date: Nov 2022 ➔ Nov 2020

Trial initiation date • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor

Study on Safety and Efficacy of NMS-01940153E in Adult Patients With Unresectable Hepatocellular Carcinoma Unresectable Hepatocellular Carcinoma (HCC) Previously Treated With Systemic Therapy (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Nerviano Medical Sciences

New P1/2 trial • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor

"#Nerviano to present #NMS01940153E (#NMS153) at #ENA22 https://t.co/bGkH3aSrPT" (@1stOncology)

Oncology