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Clinical Trials in the USA / NCT07060989
Recruiting Phase 1/2

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

NCT07060989 · tracked via the Priya Life Science USA tracker
Sponsor
Nutshell Therapeutics (Shanghai) Co., LTD.
Phase
Phase 1/2
Started
2025-08-04
Last updated
2026-06-24

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

NTS071

NTS071: Oral administration

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male or female subjects, ≥ 18 years 2. Advanced solid tumors with TP53 Y220C mutation 3. Previously treated with one or more lines of anticancer therapy and progressive disease 4. At least one measurable lesion according to RECIST version 1.1 criteria 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 6. Adequate organ and bone marrow function Exclusion Criteria: 1. Known CNS primary tumor and active or untreated CNS metastases 2. History of another primary malignancy that has been diagnosed or required therapy within the past 2 years 3. Toxicities of prior therapy have not been resolved to ≤ Grade 1 or to baseline 4. Significant cardiovascular disease, including congestive heart failure 5. Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active 6. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Next Oncology San Antonio Texas Recruiting
Shanghai Shanghai China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060989 on ClinicalTrials.gov ↗ ← All trials in the USA