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

NCT07060989 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: NTS071-101
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 2

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

Keywords

Advanced Solid Tumors; TP53 Y220C

Outcome Measures

Primary Outcomes (3)

• Phase 1: Number of dose-limiting toxicity (DLT)

  Incidence of dose-limiting toxicity (DLT) events

  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

  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)

  Up to 3 years

Secondary Outcomes (9)

• Phase 1/2a: area under the curve (AUC)

  Up to 2 years

• Phase 1/2a: maximum concentration (Cmax)

  Up to 2 years

• Phase 1/2a: half-life (t1/2) of NTS071

  Up to 2 years

• Phase 1/2a: trough observed concentrations (Ctrough/Ctau)

  Up to 2 years

• Phase 1: Objective response rate (ORR)

  Up to 3 years

Study Arms (1)

NTS071

EXPERIMENTAL

Single arm

Drug: NTS071

Interventions

NTS071 DRUG

Oral administration

NTS071

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutshell Therapeutics (Shanghai) Co., LTD.: lead

Study Sites (2)

Next Oncology

San Antonio, Texas, 78201, United States

Location

Shanghai

Shanghai, 200032, China

Location

Central Study Contacts

Jingmei Hou

CONTACT

18601779762; jingmei.hou@allonutshell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); US (1)