Actively Recruiting
Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2026-01-29
257
Participants Needed
6
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Expected survival of at least 3 months
- Willingness to use a highly effective method of birth control during the study and for 180 days after last dose
You will not qualify if you...
- Major surgery or interventional treatment within 4 weeks before first dose, except biopsy or puncture
- Anti-tumor therapy within 4 weeks before first dose, including radiotherapy, immunologic or biological therapy
- Small molecule targeted therapy or chemotherapy within 2 weeks before first dose
- Palliative radiotherapy for bone metastases within 2 weeks before first dose
- Use of nitrosoureas or mitomycin C within 6 weeks before first dose
- Live vaccines within 4 weeks before first dose
- Participation in other drug clinical trials within 4 weeks before first dose
- History of central nervous system diseases within 12 months before enrollment, including seizures, stroke, paralysis, severe brain injury, dementia, Parkinson's disease, cerebellar disease, psychiatric disease, or autoimmune disease involving CNS
- Severe pulmonary diseases such as pulmonary embolism or interstitial lung disease at screening
- Previous allogeneic tissue or solid organ transplantation
- Active infections
- Positive for HIV (HIV1/2 antibody), active chronic hepatitis B or C as defined by viral markers
- Female subjects who are lactating or pregnant during screening
- Any condition preventing compliance with study procedures or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350000
Actively Recruiting
2
Hunan Provincial Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
3
The first Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
4
Shandong Provincial Cancer Hospital
Jinan, Shandong, China, 250000
Not Yet Recruiting
5
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
6
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
K
Kai Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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