Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation

Launched by SICHUAN HUIYU PHARMACEUTICAL CO., LTD · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HYP-2090PTSA for patients who have advanced solid tumors with a specific genetic change known as a KRAS mutation. The trial has two parts: the first part will test different doses of the medication to find out which amount is the safest and most effective, while the second part will look at how well this dose works in patients with a specific type of KRAS mutation called p.G12C. The goal is to see if this treatment can help improve their condition.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of an advanced solid tumor. You should also have at least one measurable tumor that can be tracked during the study. Participants will need to give written consent before starting and must be willing to use effective birth control during the study and for some time afterward. If you join, you can expect close monitoring for safety and effectiveness, and you will be surrounded by a supportive medical team. It's important to know that there are some restrictions on who can participate, including certain recent treatments or health conditions, so discussing your individual situation with your doctor is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
• • 18 Years and older;
• • Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;
• • Subjects must have at least one measurable lesion as defined by RECIST v1.1;
• • Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
• • Expected survival ≥ 3 months;
• • Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.
• Exclusion Criteria:
• • Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;
• • Patients who have received live vaccines within 4 weeks prior to the first dose;
• • Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;
• • Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;
• • Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;
• • Patients who have previously received allogeneic tissue/solid organ transplantation;
• • Patients with active infection;
• • Patients who are positive for human immunodeficiency virus (HIV) (HIV1/2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \> 500 IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA \> lower limit of detection by the research center);
• • Female subjects who are lactating or have a positive blood/urine pregnancy result during the screening period;
• • Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.