NCT07060989 · Nutshell Therapeutics (Shanghai) Co., LTD.
A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
(NTS071)
What this study is about
This study is to evaluate the safety, tolerability, PK, and preliminary effectiveness of NTS071 in adults with TP53 Y220C-mutated solid tumors.
View original scientific description
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
Interventions
DRUG
NTS071
Oral administration
Primary outcome measures
Phase 1: Number of dose-limiting toxicity (DLT)
Time frame: The first 26 days of treatment (Cycle 1) per patient
Incidence of dose-limiting toxicity (DLT) events
Phase 1: incidence of adverse events (AE), serious adverse events (SAEs)
Time frame: up to 30 days after the last administration
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Phase 2a: Overall Response Rate (ORR)
Time frame: Up to 3 years
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations