Clinical trial NCT06243354: Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Safety
Tolerability
Efficacy
Lead sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recommended phase-2 dose (RP2D)
timeFrame: Approximately 2 years
measure: Number of participants with dose limiting toxicities
timeFrame: 24 days
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Approximately 2 years
measure: Objective response rate (ORR)
timeFrame: Approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Changsha
country: China
facility: Hunan Provincial Cancer Hospital
state: Hunan
city: Shenyang
country: China
facility: The first Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: