Overview
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
Description
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.
Eligibility
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
Exclusion 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
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
- Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
