Not Yet RecruitingPhase 1/2

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

United States, China220 participantsStarted 2025-08

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Phase 1: Number of dose-limiting toxicity (DLT)

Timeframe: The first 26 days of treatment (Cycle 1) per patient

Phase 1: incidence of adverse events (AE), serious adverse events (SAEs)

Timeframe: up to 30 days after the last administration

Phase 2a: Overall Response Rate (ORR)

Timeframe: Up to 3 years

NCT IDNCT07060989

SponsorNutshell Therapeutics (Shanghai) Co., LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Jingmei Hou

Who can participate