SA53-OS / Lamassu Bio - LARVOL DELTA

First-in-human study of SA53, a novel MDM2 inhibitor, demonstrates favorable safety and dose-dependent pharmacokinetics in advanced solid tumors. (ESMO 2026) - No abstract available

Clinical • First-in-human • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor

First-in-human study of SA53-OS, an oral MDM2 inhibitor, in advanced p53 wild-type solid tumors (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

First-in-human • Metastases • P1 data • P53WT • Oncology • Solid Tumor

LB-SA53-101: Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Lamassu Bio Inc | Trial primary completion date: Mar 2026 ➔ Dec 2026

P53WT • Trial primary completion date • Oncology • Solid Tumor • MDM2

LB-SA53-101: Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Lamassu Bio Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

LB-SA53-101: Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Lamassu Bio Inc | Trial completion date: Jun 2028 ➔ Dec 2028 | Initiation date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Lamassu Bio Inc

New P1/2 trial • Oncology • Solid Tumor

Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol (PRNewswire) - "More hope for successfully combating some of the deadliest cancers. Lamassu Biotech is proud to announce its pioneering effort to combat locally advanced metastatic p53 wild-type tumors has earned investigational new drug application (IND) approval from the Food and Drug Administration (FDA) to proceed in initiate Phase 1/2a clinical trials....The trial will investigate novel therapy SA53-OS, a genetically targeted therapy that targets the MDM2 protein, a key regulator of the tumor suppressor p53 gene. By selectively activating p53, Lamassu aims to induce tumor cell death and inhibit growth, potentially providing a much-needed breakthrough in targeted cancer therapy."

IND • New P1/2 trial • Oncology

Lamassu Awarded NIH Grant For Breakthrough Cancer Treatment (PRNewswire) - "Lamassu Bio Inc., a cutting-edge biotech company dedicated to innovative cancer therapies, has been awarded a grant from the National Institutes of Health (NIH) and National Cancer Institute ( NCI) for the development of their groundbreaking treatment for p53 wild-type sarcomas. The $2.05 million grant will help fund the clinical trial integral to this new cancer treatment. The trial will be conducted in collaboration with Cleveland Clinic Taussig Cancer Center and Cleveland Clinic Children's Pediatric Hematology and Oncology Department....The project focuses on advancing SA53, a novel therapeutic that targets p53 wild-type sarcomas, malignant tumors of connective or non-epithelial tissue."

Financing • Oncology • Sarcoma • Solid Tumor