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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Test product: HYP-2090PTSA
DrugDosage form: Capsule. Strength: 2.5 mg, 5 mg and 10mg. Method of administration: Take orally on an empty stomach. Do not chew. Swallow the product with warm water. Dose Escalation Phase PK Lead-in Period (C0D1 only): Take once (QD dosing regimen only). Starting from C1D1, and in the Dose Expansion part, subjects will take the protocol-specified dose of HYP-2090PTSA orally in the morning on an empty stomach and one hour before the evening meal (evening dosing applies to BID regimen only), administered once to twice daily or two to three times per week. The administration dosages are: QD (once daily); BID (twice daily); TIW (on Days 1, 3, and 5 of each week); BIW (on Days 1 and 4 of each week). Avoid drinking water as much as possible within 1 hour before and after dosing (except for the water taken with the medication). Do not re-administer the dose if vomiting occurs after drug intake.
Treatment groups
257 Participants
are divided into 1 treatment groupGroup A: Test product-HYP-2090PTSAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended phase-2 dose (RP2D)
RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data
Time frame
Approximately 2 years2
Number of participants with dose limiting toxicities
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period
Time frame
24 daysSecondary outcomes
1
Number of participants with Adverse Events (AEs)
All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments
Time frame
Approximately 2 years2
Objective response rate (ORR)
ORR is defined as the proportion of participants with confirmed complete response or partial response
Time frame
Approximately 2 years3
Progression-free survival (PFS)
Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1
Time frame
Approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov