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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNutshell Therapeutics (Shanghai) Co., LTD.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • NTS071

Treatment groups

220 Participants
are divided into 1 treatment group