NTS071 / NUTSHELL Therapeutics - LARVOL DELTA

A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (clinicaltrials.gov) - P1/2 | N=220 | Not yet recruiting | Sponsor: Nutshell Therapeutics (Shanghai) Co., LTD.

New P1/2 trial • Solid Tumor

FDA Greenlights IND for NTS071, Nutshell Therapeutics’ Cancer Drug - "NTS071 demonstrated potential Best-in-Class preclinical properties for its target. NTS071 achieved a picomolar-level biochemical activity which is 20 folds more potent than the competitive compound PC14586. Additionally, NTS071 shows better stability in both liver microsomes and hepatocytes across different species and exhibits lower in vivo clearance rates and higher oral exposure s in preclinical PK studies across all tested species compared to PC14586."

Preclinical • Bladder Cancer • Breast Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

IND Application for NTS071, Nutshell Therapeutics’ p53 Y220C Allosteric Reactivator, Received US FDA clearance (PRNewswire) - "On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate Phase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric reactivator targeting p53 Y220C mutation....NTS071 is anticipated to initiate Phase 1 clinical trial in second half of 2025 and expected to benefit patients with solid tumors harboring this mutation."

IND • New P1 trial • Oncology • Solid Tumor