This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
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
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
Single group
NTS071
DrugOral administration
Phase 1: Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events
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
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)
Phase 1/2a: area under the curve (AUC)
PK parameters to be evaluated for NTS071 including area under the curve (AUC) will be determined when appropriate.
Phase 1/2a: maximum concentration (Cmax)
PK parameters to be evaluated for NTS071 including maximum concentration (Cmax) will be determined when appropriate.
Phase 1/2a: half-life (t1/2) of NTS071
PK parameters to be evaluated for NTS071 including half-life (t1/2) will be determined when appropriate.
Phase 1/2a: trough observed concentrations (Ctrough/Ctau)
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of NTS071
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