Actively Recruiting
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-12-05
153
Participants Needed
2
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors. The study consists of dose escalation, dose expansion and efficacy expansion.
CONDITIONS
Official Title
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must understand the study and agree to sign the informed consent form
- Age between 18 and 75 years, any gender
- Histologically or cytologically confirmed advanced solid tumors with KRAS G12D mutations
- Have failed, are intolerant to, or have not received standard treatment
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- At least one measurable lesion as per RECIST v1.1 and able to provide tumor tissue sample
- Adequate organ function
You will not qualify if you...
- Toxicity from prior anti-tumor treatment not recovered to Grade 3 or better
- Presence of central nervous system metastases
- Gastrointestinal diseases affecting drug absorption or administration
- Major surgery within 28 days before first dose or planned major surgery during study
- Presence of serious lung diseases
- Active tuberculosis or history of active tuberculosis within 48 weeks prior to screening
- Active or persistent gastrointestinal bleeding within 6 months prior to screening
- History of allogeneic bone marrow or solid organ transplantation
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring treatment
- Positive HIV test or active chronic hepatitis B or C infection
- Known allergy to any components of the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
R
Rongfu Mao
CONTACT
J
Jizhao Li
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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