A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation

This is a Phase 1/2a, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary efficacy of NTS071 in subjects with unresectable locally advanced or metastatic solid tumors containing a TP53 Y220C mutation.

This study includes two parts: Phases 1 and 2a. The Phase 1 part consists of the dose escalation and backfill part; The Phase 2a part consists of the cohort expansion part.

Inclusion criteria

• Male or female subjects, ≥ 18 years
• Advanced solid tumors with TP53 Y220C mutation
• Previously treated with one or more lines of anticancer therapy and progressive disease
• At least one measurable lesion according to RECIST version 1.1 criteria
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• Adequate organ and bone marrow function

Exclusion criteria

• Known CNS primary tumor and active or untreated CNS metastases
• History of another primary malignancy that has been diagnosed or required therapy within the past 2 years
• Toxicities of prior therapy have not been resolved to ≤ Grade 1 or to baseline
• Significant cardiovascular disease, including congestive heart failure
• Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
• Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.