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New treatment option for Solid Tumors Harboring a TP53 Y220C Mutation
Official title A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
ClinicalTrials.gov ID: NCT06908434
What this study is testing
What is GenSci128 tablets?
GenSci128 tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumors harboring a tp53 y220c mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any...
- Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
- Has confirmed TP53 Y220C mutation in tumor tissue
- Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for...
- Has at least one measurable lesion by RECIST v1.1
You likely can't join if
- Has diagnosed as primary central nervous system (CNS) tumor.
- Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of...
- Has a history of leptomeningeal disease or spinal cord compression.
- Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
- Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections...
- Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
See the full eligibility criteria
- Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)
- Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
- Has confirmed TP53 Y220C mutation in tumor tissue
- Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective...
- Has at least one measurable lesion by RECIST v1.1
- Has an ECOG status of 0 or 1
- Has a life expectancy of ≥ 3 months.
- Has diagnosed as primary central nervous system (CNS) tumor.
- Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
- Has a history of leptomeningeal disease or spinal cord compression.
- Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
- Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which...
- Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
- Has a history of prior organ transplant or allogeneic stem cell transplant.
- Has received a selective reactivator of p53 Y220C mutation.
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
- Has known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies) or known chronic hepatitis B or C [participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb)...
- Is persisting toxicity related to prior anticancer therapy (NCI CTCAE V5.0 Grade\>1). However, alopecia and sensory neuropathy Grade ≤2, or other Grade ≤2 adverse events not constituting a safety risk, based on the...
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or GenSci128 administration or may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.