A Study of Safety, Tolerability and Preliminary Efficacy of NTS071 in Subjects With Advanced Solid Tumors Harboring a TP53 Y220C Mutation
NCT ID: NCT07060989
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2025-08-31
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NTS071
Single arm
NTS071
Oral administration
Interventions
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NTS071
Oral administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Nutshell Therapeutics (Shanghai) Co., LTD.
INDUSTRY
Responsible Party
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Locations
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Next Oncology
San Antonio, Texas, United States
Shanghai
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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NTS071-101
Identifier Type: -
Identifier Source: org_study_id
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