Recruiting
Phase 1
Phase 2

NTS071

Sponsor:

Nutshell Therapeutics (Shanghai) Co., LTD.

Code:

NCT07060989

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NTS071

Study Details

Brief summary:

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

Conditions

Advanced Solid Tumors

Study ID

NCT07060989

Start date

Aug 4, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTS071

Single arm

Interventions

NTS071

Oral administration

Primary outcome measure

  • Phase 1: Number of dose-limiting toxicity (DLT) [ Time Frame: The first 26 days of treatment (Cycle 1) per patient ]
  • Phase 1: incidence of adverse events (AE), serious adverse events (SAEs) [ Time Frame: up to 30 days after the last administration ]
  • Phase 2a: Overall Response Rate (ORR) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Next Oncology

Recruiting

San Antonio, Texas, United States, 78201

More Information

Sponsor

Nutshell Therapeutics (Shanghai) Co., LTD.

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Advanced Solid Tumors
  • TP53 Y220C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nutshell Therapeutics (Shanghai) Co., LTD. on 2026-06-24.