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

Last updated: March 31, 2025
Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Test product: HYP-2090PTSA

Clinical Study ID

NCT06243354
HY0002-101
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • A written informed consent should be signed by a subject or his/her legalrepresentative before any study-related procedures are performed;

  • 18 Years and older;

  • Subjects with histologically or cytologically confirmed locally advanced ormetastatic 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 thestudy, and for at least 180 days after the last dose of study medication.

Exclusion

Exclusion Criteria:

  • Patients who have received major surgical or interventional treatment within 4 weeksprior to the first dose, with the exception of tumor biopsy, puncture, etc. Patientswho have received anti-tumor therapy (radiotherapy, immunologic therapy orbiological therapy) within 4 weeks, prior to the first dose, or received smallmolecular targeted therapy, chemotherapy within 2 weeks, or received palliativeradiotherapy for bone metastases within 2 weeks, or received nitrosoureas ormitomycin 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 4weeks before the first dose;

  • Patients with a history of central nervous system disease within 12 months prior toenrollment, 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 withinvolvement of the central nervous system;

  • Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lungdisease 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 isrequired to undergo a confirmatory test, and those with negative confirmatory testcan be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA > 500IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA > lower limit ofdetection by the research center);

  • Female subjects who are lactating or have a positive blood/urine pregnancy resultduring the screening period;

  • Any other condition of the subject (e.g., mental, geographical, or medicalcondition) that does not allow him or her to comply with the study and follow-upprocedures, or other conditions that, in the judgment of the investigator, thesubject is not suitable for inclusion in this study.

Study Design

Total Participants: 257
Treatment Group(s): 1
Primary Treatment: Test product: HYP-2090PTSA
Phase: 1/2
Study Start date:
February 04, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

  • Hunan Provincial Cancer Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • The first Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Shandong Provincial Cancer Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.