An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation

Sichuan Huiyu Pharmaceutical Co., Ltd6 sites in 1 country257 target enrollmentFebruary 4, 2024

ConditionsSafety Tolerability Efficacy

InterventionsTest product: HYP-2090PTSA

DrugsTest product: HYP-2090PTSA

Overview

Phase: Phase 1
Intervention: Test product: HYP-2090PTSA
Conditions: Safety
Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd
Enrollment: 257
Locations: 6
Primary Endpoint: Recommended phase-2 dose (RP2D)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 4, 2024

End Date

December 1, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan Huiyu Pharmaceutical Co., Ltd

Responsible Party

Sponsor

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.

Arms & Interventions

Test product-HYP-2090PTSA

Intervention: Test product: HYP-2090PTSA

Outcomes

Primary Outcomes

Recommended phase-2 dose (RP2D)

Time Frame: Approximately 2 years

RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data

Number of participants with dose limiting toxicities

Time Frame: 24 days

Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period