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

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243354
• Other study ID #: HY0002-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 4, 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Sichuan Huiyu Pharmaceutical Co., Ltd
• Contact: Kai Chang
• Phone: +86-028-86021875
• Email: kai.chang4086[@]huiyupharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 257
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy
• Safety
• Tolerability

Intervention

Drug:
• Test product: HYP-2090PTSA
Dosage form: Capsule. Strength: 2.5 mg, 5 mg. Method of administration: Oral; Dose escalation: a fixed dose QD is planned, and all other dose levels and administration methods are temporary with the exception of the initial dose. Dose expansion: the dose and method of administration are conducted as discussed by the sponsor and investigators. Medication cycle: Take orally under fasting condition every morning, with 21 days as a cycle (tentative), and continue taking until disease progression, or intolerable toxicity, or withdrawal of informed consent, or treatment with another antitumor drug, or the death of the subject, or loss to follow-up (whichever occurs earliest).

Locations

Country	Name	City	State
China	Hunan Provincial Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Shandong Provincial Cancer Hospital	Jinan	Shandong
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	The first Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Huiyu Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 2 years
Primary	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	24 days
Secondary	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	Approximately 2 years
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of participants with confirmed complete response or partial response	Approximately 2 years
Secondary	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	Approximately 2 years