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Recruiting NCT07060989

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

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NTS071.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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]
  • 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]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Next Oncology — San Antonio
China · 1 center
  • Shanghai — Shanghai

Identifiers

NCT: NCT07060989 · NTS071-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗