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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTS071 | Experimental | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTS071 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of dose-limiting toxicity (DLT) | Incidence of dose-limiting toxicity (DLT) events | 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 | 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) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2 years |
| Phase 1/2a: maximum concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu | Contact | +86 13585878226 | yan.xu@allonutshell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Next Oncology | Recruiting | San Antonio | Texas | 78201 | United States | |
| Shanghai |
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PK parameters to be evaluated for NTS071 including maximum concentration (Cmax) will be determined when appropriate.
| 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. | 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 | Up to 2 years |
| Phase 1: Objective response rate (ORR) | To evaluate the preliminary antitumor activity of NTS071 | Up to 3 years |
| Phase 1/2a: duration of response (DoR) | To evaluate the preliminary anti-tumor activity of NTS071 | Up to 3 years |
| Phase 1/2a: disease control rate (DCR) | To evaluate the preliminary antitumor activity of NTS071 | Up to 3 years |
| Phase 1/2a: progression-free survival (PFS) | To evaluate the preliminary antitumor activity of NTS071 | Up to 3 years |
| Phase 1/2a: Overall survival (OS) | To evaluate the preliminary antitumor activity of NTS071 | Up to 3 years |
| Recruiting |
| Shanghai |
| 200032 |
| China |