Actively Recruiting
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-09-22
118
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
CONDITIONS
Official Title
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Age 18-75 years old (inclusive) at time of consent
- Male or female
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
You will not qualify if you...
- Any condition increasing risk, interfering with study results, or unsuitable for participation
- Uncontrollable psychiatric illness, known alcoholism, drug or substance abuse, or criminal detention
- Known hypersensitivity to HRS-4642 components or severe allergic reactions to monoclonal antibodies or antineoplastic agents
- Major surgery within 28 days before first dose, minor surgery within 7 days, or presence of non-healing wounds or untreated fractures
- Participation in other clinical studies with less than 4 weeks since last dose or within 5 half-lives of investigational drug
- Use of live attenuated vaccine within 28 days before first dose or planned during treatment
- History of immunodeficiency, including positive HIV test or organ transplantation
- Active pulmonary tuberculosis within 1 year or untreated history of tuberculosis over 1 year ago
- Active hepatitis B infection
- Clinically significant acute or chronic pancreatitis
- Poorly controlled or severe cardiovascular or cerebrovascular diseases, or thrombotic events within 6 months before study
- Gastrointestinal obstruction or symptoms within 6 months before treatment unless fully resolved by surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
H
Hongxia Han
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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