ISM6331 / Insilico Medicine - LARVOL DELTA

First-in-human Multicenter Phase 1 Study of ISM6331, an AI-Designed Pan-TEAD Inhibitor, in Patients with Mesothelioma or Other Advanced Solid Tumors (ESMO 2026) - No abstract available

Clinical • First-in-human • Metastases • P1 data • Mesothelioma • Oncology • Solid Tumor

Insilico Medicine to present first-in-human data for AI-designed pan-TEAD inhibitor ISM6331 at ESMO 2026 (Eurekalert) - "The presentation will provide the first reported clinical findings from the global, multicenter first-in-human study of ISM6331 in patients with advanced solid tumors."

First-in-human • P1 data • Solid Tumor

Study of ISM6331 in Participants With Advanced/Metastatic Mesothelioma or Other Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: InSilico Medicine Hong Kong Limited | Phase classification: P1 ➔ P1/2 | N=100 ➔ 160

Enrollment change • First-in-human • Phase classification • Mesothelioma • Oncology • Solid Tumor

Insilico Medicine Receives FDA Fast Track Designation for ISM6331, the AI-driven Pan-TEAD Inhibitor, in Advanced Mesothelioma (Insilico Medicine Press Release) - "...Its initial Phase I first-in-human clinical data has been accepted for a brief oral presentation at the upcoming ESMO 2026 Congress."

Fast track • First-in-human • P1 data • Malignant Pleural Mesothelioma

Insilico Medicine Announces Oral Presentation at ESMO 2026 for Phase 1 Clinical Study of ISM6331 in Mesothelioma and Advanced Solid Tumors (PRNewswire) - "Global Phase 1 multicenter study evaluates safety, tolerability, and preliminary efficacy in patients with mesothelioma and other advanced solid tumors."

First-in-human • P1 data • Mesothelioma • Solid Tumor

ISM6331, a novel and potent pan-TEAD inhibitor, exhibits strong anti-tumor activity in preclinical models of Hippo pathway-dysregulated cancers (AACR 2024) - "In addition, ISM6331 showed excellent pharmacokinetic properties in multiple preclinical species and was well-tolerated in GLP-toxicity studies. In summary, ISM6331 has promising potential to treat Hippo pathway-dysregulated tumors as monotherapy as well as in combination with targeted therapies."

Preclinical • Mesothelioma • Oncology • Solid Tumor • KRAS • LATS1 • TEAD1

Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: InSilico Medicine Hong Kong Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Mesothelioma • Oncology • Solid Tumor

Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: InSilico Medicine Hong Kong Limited

Metastases • New P1 trial • Mesothelioma • Oncology • Solid Tumor

Insilico Medicine received IND approval and orphan drug designation from FDA for ISM6331, an AI-designed TEAD inhibitor targeting solid tumors and mesothelioma (Eurekalert) - "Insilico Medicine...announced ISM6331, potential best-in-class pan-TEAD inhibitor, has received the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance for the treatment of mesothelioma, following the grant of Orphan Drug Designation (ODD) in June 2024."

IND • New trial • Orphan drug • Mesothelioma • Oncology • Solid Tumor