Clinical trial · Interventional
A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
A Phase 1/2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
NCT07060989CI-TRIAL-00115724NTS071recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the safety, tolerability, PK, and preliminary efficacy of NTS071 in adults with TP53 Y220C-mutated solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NTS071 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NTS071
- description
- Single arm
- interventionNames
- Drug: NTS071
Primary outcomes (3)
- measure
- Phase 1: Number of dose-limiting toxicity (DLT)
- timeFrame
- The first 26 days of treatment (Cycle 1) per patient
- description
- Incidence of dose-limiting toxicity (DLT) events
- measure
- Phase 1: incidence of adverse events (AE), serious adverse events (SAEs)
- timeFrame
- up to 30 days after the last administration
- description
- Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female subjects, ≥ 18 years 2. Advanced solid tumors with TP53 Y220C mutation 3. Previously treated with one or more lines of anticancer therapy and progressive disease 4. At least one measurable lesion according to RECIST version 1.1 criteria 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 6. Adequate organ and bone marrow function Exclusion Criteria: 1. Known CNS primary tumor and active or untreated CNS metastases 2. History of another primary malignancy that has been diagnosed or required therapy within the past 2 years 3. Toxicities of prior therapy have not been resolved to ≤ Grade 1 or to baseline 4. Significant cardiovascular disease, including congestive heart failure 5. Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active 6. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.