Actively Recruiting
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-12-30
82
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
CONDITIONS
Official Title
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability and willingness to sign a written informed consent form before starting the study drug and procedures
- Willingness and ability to follow scheduled visits, treatment plan, lab tests, and study procedures
- Confirmed TP53 Y220C mutation in tumor tissue
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have progressed after standard therapy or lack effective standard treatment
- At least one measurable lesion as defined by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
You will not qualify if you...
- Diagnosis of primary central nervous system (CNS) tumor
- Presence of CNS metastases unless asymptomatic, stable, and without steroid treatment for at least 2 weeks before starting GenSci128
- History of leptomeningeal disease or spinal cord compression
- Stroke or transient ischemic attack within 6 months before starting GenSci128
- Active infection requiring intravenous antibiotics or uncontrolled illness needing hospitalization (minor infections treatable by short-term oral antibiotics allowed)
- Uncontrolled high blood pressure (≥150/90 mmHg) despite optimal treatment
- History of prior organ or allogeneic stem cell transplant
- Previous treatment with a selective reactivator of p53 Y220C mutation
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage (recurrence within 14 days after intervention)
- Known HIV infection or chronic hepatitis B or C infection with detectable viral DNA or RNA
- Persistent toxicity from prior cancer therapy above grade 1 except alopecia and sensory neuropathy grade ≤2 or other grade ≤2 adverse events not posing safety risks
- Severe acute or chronic medical or psychiatric condition or lab abnormality that increases risk or interferes with study participation or results, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital ,Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wen Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here