A Study of NTS071 for Advanced Solid Tumors with TP53 Y220C Mutation
This study is testing a new oral drug called NTS071 for people with advanced solid tumors that have a specific genetic change called a TP53 Y220C mutation. You might be able to join if you are at least 18 years old, have advanced solid tumors with this mutation, have already received other cancer treatments, and have tumors that can be measured. The main goals are to see how safe NTS071 is, how well your body tolerates it, and if it can shrink tumors. This study is currently in an unclear status regarding recruitment and plans to enroll about 220 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know you are receiving NTS071. It is a Phase 1/2a study, which means it will first look at safety and then at how well the drug works.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for up to 30 days after your last dose, and tumor response for up to 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Phase 1: Number of dose-limiting toxicity (DLT)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)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)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)