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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT07060989

Run by

Nutshell Therapeutics (Shanghai) Co., LTD.

People needed

220

Starts

2025-08-04

Expected to finish

2029-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Next Oncology — San Antonio, Texas, United States (enrolling)
• Shanghai — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.