RecruitingPhase 1Phase 2NCT07060989

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

A Phase 1/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation

Sponsor

Nutshell Therapeutics (Shanghai) Co., LTD.

Enrollment

220 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

Summary

This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria6

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.