NCT06243354 Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation

Trial Parameters

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Brief Summary

This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

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 the

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