A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called GenSci128, which is being tested in patients who have certain types of solid tumors that carry a specific genetic mutation known as TP53 Y220C. The main goal of the study is to see how safe GenSci128 is, how well it works, and how the body processes it. This trial is currently not recruiting participants, but when it does, it will include adults aged 65 to 74 who have advanced cancer that has not responded to standard treatments.

To be eligible for this trial, participants need to confirm they have the TP53 Y220C mutation in their tumor tissue and have measurable cancer that has either progressed after standard therapy or where no effective treatment is available. They should also be able to understand the study and follow the treatment plan, attend scheduled visits, and have a life expectancy of at least three months. Participants will be closely monitored throughout the study, and their experiences will help researchers understand how GenSci128 affects patients with this specific type of cancer. It's important to note that individuals with certain health conditions, such as active infections or uncontrolled blood pressure, may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 2. Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
• • 3. Has confirmed TP53 Y220C mutation in tumor tissue
• • 4. 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 standard therapy exists.
• • 5. Has at least one measurable lesion by RECIST v1.1
• • 6. Has an ECOG status of 0 or 1
• • 7. Has a life expectancy of ≥ 3 months.
• Exclusion Criteria:
• • 1. Has diagnosed as primary central nervous system (CNS) tumor.
• • 2. Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
• • 3. Has a history of leptomeningeal disease or spinal cord compression.
• • 4. Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
• • 5. 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 may be treated with short term oral antibiotics are allowed.
• • 6. Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
• • 7. Has a history of prior organ transplant or allogeneic stem cell transplant.
• • 8. Has received a selective reactivator of p53 Y220C mutation.
• • 9. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
• • 10. Has known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies) or known chronic hepatitis B or C \[participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA; participants positive for hepatitis C virus (HCV) IgG will be eligible if they are negative for HCV-RNA\].
• • 11. 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 investigator's judgment are acceptable.
• • 12. 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 interpretation of study results, in the judgment of the investigator, would make the participant inappropriate for entry into this study.