Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Huiyu Pharmaceutical Co., Ltd
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Test product: HYP-2090PTSA
Treatment groups
257 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov