Advanced Solid TumorsPhase 1/2NTS071NCT07060989
A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
A Phase 1/2 study testing NTS071 in people with Advanced Solid Tumors, run by Nutshell Therapeutics (Shanghai) Co., LTD. at 10 sites in 2 countries.
Trial summary
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NTS071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 4 Aug 2025to Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
China7 sites, 7 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510120
- Recruiting
The First Affiliated Hospital of Nanchang University - Xianghu District
Nanchang, 330019
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
United States3 sites, 3 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 200031
Maybelle De La Rosa, 703-783-4518, mdelarosa@nextoncology.com
Alexander Spira, M.D.
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ecaterina Dumbrava, 713-792-3934, EEIleana@mdanderson.org
Ecaterina Dumbrava, M.D.
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 200031
Ingrid Palma, 203-833-1034, ingrid.palma@yale.edu
Patricia LoRusso, M.D.
About this study
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
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
Read the detailed description
This is a Phase 1/2a, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary efficacy of NTS071 in subjects with unresectable locally advanced or metastatic solid tumors containing a TP53 Y220C mutation.
This study includes two parts: Phases 1 and 2a. The Phase 1 part consists of the dose escalation and backfill part; The Phase 2a part consists of the cohort expansion part.
- Conditions
- Advanced Solid Tumors
- Being tested
- NTS071
- Keywords
- Advanced Solid Tumors, TP53 Y220C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTS071Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| NTS071 | Experimental | Single arm Receives: Drug: NTS071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events
Measured: The first 26 days of treatment (Cycle 1) per patient
Phase 1: incidence of adverse events (AE), serious adverse events (SAEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Measured: up to 30 days after the last administration
Phase 2a: Overall Response Rate (ORR)
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)
Measured: Up to 3 years
Secondary outcomes (9)
Phase 1/2a: area under the curve (AUC)
PK parameters to be evaluated for NTS071 including area under the curve (AUC) will be determined when appropriate.
Measured: Up to 2 years
Phase 1/2a: maximum concentration (Cmax)
PK parameters to be evaluated for NTS071 including maximum concentration (Cmax) will be determined when appropriate.
Measured: Up to 2 years
Phase 1/2a: half-life (t1/2) of NTS071
PK parameters to be evaluated for NTS071 including half-life (t1/2) will be determined when appropriate.
Measured: Up to 2 years
Phase 1/2a: trough observed concentrations (Ctrough/Ctau)
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of NTS071
Measured: Up to 2 years
Phase 1: Objective response rate (ORR)
To evaluate the preliminary antitumor activity of NTS071
Measured: Up to 3 years
Phase 1/2a: duration of response (DoR)
To evaluate the preliminary anti-tumor activity of NTS071
Measured: Up to 3 years
Phase 1/2a: disease control rate (DCR)
To evaluate the preliminary antitumor activity of NTS071
Measured: Up to 3 years
Phase 1/2a: progression-free survival (PFS)
To evaluate the preliminary antitumor activity of NTS071
Measured: Up to 3 years
Phase 1/2a: Overall survival (OS)
To evaluate the preliminary antitumor activity of NTS071
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start4 Aug 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutshell Therapeutics (Shanghai) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060989
- Sponsor's protocol ID
- NTS071-101
- Acronym
- NTS071
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07060989
- Acronym / sponsor ID
- NTS071 / NTS071-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, TP53 Y220C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Nutshell Therapeutics (Shanghai) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
Detailed description
This is a Phase 1/2a, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary efficacy of NTS071 in subjects with unresectable locally advanced or metastatic solid tumors containing a TP53 Y220C mutation.
This study includes two parts: Phases 1 and 2a. The Phase 1 part consists of the dose escalation and backfill part; The Phase 2a part consists of the cohort expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTS071 | Experimental | Drug: NTS071Single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTS071Oral administration | Drug | NTS071 |
Primary outcome
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)
9 secondary outcomes
Phase 1/2a: area under the curve (AUC)
Time frame: Up to 2 years
Phase 1/2a: maximum concentration (Cmax)
Time frame: Up to 2 years
Phase 1/2a: half-life (t1/2) of NTS071
Time frame: Up to 2 years
Phase 1/2a: trough observed concentrations (Ctrough/Ctau)
Time frame: Up to 2 years
Phase 1: Objective response rate (ORR)
Time frame: Up to 3 years
Phase 1/2a: duration of response (DoR)
Time frame: Up to 3 years
Phase 1/2a: disease control rate (DCR)
Time frame: Up to 3 years
Phase 1/2a: progression-free survival (PFS)
Time frame: Up to 3 years
Phase 1/2a: Overall survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NTS071 in people with Advanced Solid Tumors, run by Nutshell Therapeutics (Shanghai) Co., LTD. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu (+86 19535820351, nts071-101-mm@allonutshell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of dose-limiting toxicity (DLT) (time frame: The first 26 days of treatment (Cycle 1) per patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.