This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Oral administration
Next Oncology
San Antonio, Texas, United States
Shanghai
Shanghai, China
Phase 1: Number of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) events
Time frame: 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
Time frame: 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)
Time frame: Up to 3 years
Phase 1/2a: area under the curve (AUC)
PK parameters to be evaluated for NST071 including area under the curve (AUC) will be determined when appropriate.
Time frame: Up to 2 years
Phase 1/2a: maximum concentration (Cmax)
PK parameters to be evaluated for NTS071 including maximum concentration (Cmax) will be determined when appropriate.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Phase 1/2a: trough observed concentrations (Ctrough/Ctau)
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of NTS071
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 2 years
Phase 1: Objective response rate (ORR)
To evaluate the preliminary antitumor activity of NTS071
Time frame: Up to 3 years
Phase 1/2a: duration of response (DoR)
To evaluate the preliminary anti-tumor activity of NTS071
Time frame: Up to 3 years
Phase 1/2a: disease control rate (DCR)
To evaluate the preliminary antitumor activity of NTS071
Time frame: Up to 3 years
Phase 1/2a: progression-free survival (PFS)
To evaluate the preliminary antitumor activity of NTS071
Time frame: Up to 3 years
Phase 1/2a: Overall survival (OS)
To evaluate the preliminary antitumor activity of NTS071
Time frame: Up to 3 years