NTS071 / NUTSHELL Therapeutics - LARVOL DELTA

Preclinical combination study of NTS071 and venetoclax for the treatment of TP53 Y220C-mutated acute myeloid leukemia (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • TP53

NTS071-101: 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 | Recruiting | Sponsor: Nutshell Therapeutics (Shanghai) Co., LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • TP53

NTS071-101: A phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of NTS071 in patients with advanced solid tumors harboring a TP53 Y220C mutation (AACR 2026) - "In preclinical studies, NTS071 has demonstrated superior in vitro potency, favorable ADME/T profile, and enhanced in vivo antitumor efficacy versus PC14586 (an investigational drug with the same targeting mechanism). Exploratory objectives are to evaluate the correlations between NTS071's pharmacodynamic profiles, efficacy outcomes, and relevant biomarkers.Summary: The first-in-human trial of NTS071 marks a critical milestone in advancing such precision oncology therapies for those patients with limited treatment options and poor prognosis. The first patient for NTS071-101 enrolled in August 2025, with active recruitment continuing in both the U.S. and China."

Clinical • First-in-human • Metastases • P1/2 data • PK/PD data • Oncology • Solid Tumor • TP53

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