NTS071 safety and early effectiveness in TP53 Y220C-mutated advanced solid tumors
Official title: 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
Run by Nutshell Therapeutics (Shanghai) Co., LTD. · NCT07060989 · Data updated 2026-11-12
This study tests NTS071 in adults with TP53 Y220C-mutated advanced solid tumors to see if it is safe and tolerable and if there are signs of activity.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Nutshell Therapeutics (Shanghai) Co., LTD. Industry-sponsored |
| Locations | 10 sites (New Haven, Connecticut and 9 other locations) |
| Status | Recruiting |
| Started | August 4, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07060989 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with advanced TP53 Y220C-mutated solid tumors that have progressed after prior therapy and have measurable disease.
✕Probably not a fit
Patients without TP53 Y220C mutation, with non-measurable disease, or without any signs of clinical activity may not derive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, multi-center Phase 1/2a trial evaluating NTS071 in unresectable locally advanced or metastatic TP53 Y220C-mutated solid tumors. The study starts with dose escalation and backfill to identify a safe dose, followed by a cohort expansion at the recommended dose. It is open-label and aims to characterize safety, pharmacokinetics, and preliminary efficacy, with measurable disease assessments by RECIST 1.1.
Why it matters
Potential benefit: If successful, participants may experience disease control signals and contribute to the development of a targeted therapy for TP53 Y220C-mutant cancers.
How similar studies have gone: Prior studies of targeted agents for TP53 mutations have shown early signals in some contexts, but this exact approach is investigational and its success remains under evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Yale Cancer Center
New Haven, Connecticut, United States Recruiting -
University of Texas MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
NEXT Virginia
Fairfax, Virginia, United States Recruiting -
Peking University People's Hospital
Beijing, China Recruiting -
Beijing Cancer Hospital
Beijing, China Recruiting -
The First Affiliated Hospital of Nanchang University - Xianghu District
Nanchang, China Recruiting
Show 4 more locations
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Fudan University Shanghai Cancer Center
Shanghai, China Recruiting -
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China Recruiting -
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China Recruiting -
Guangdong Provincial People's Hospital
Guangzhou, China Not yet recruiting
Study contacts
- Study coordinator: Yan Xu
- Email: nts071-101-mm@allonutshell.com
- Phone: +86 19535820351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.