To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors
NCT ID:
NCT06520488
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642
Description:
Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II:
HRS-4642 combined with SHR-A1904 Treatment group Part II: HRS-4642 combined with AG
Arm group label:
Treatment group Part I/Part II/Part III
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Age 18-75 years old (inclusive) at the time of signing the informed consent form
3. Male or female
4. ECOG score of 0 or 1
5. Expected survival ≥ 12 weeks
6. At least one measurable lesion according to RECIST v1.1 criteria
Exclusion Criteria:
1. Any other condition that, in the judgment of the investigator, may increase the risk
of participating in the study, interfere with the results of the study, or be
unsuitable for participation in this study
2. Presence of uncontrollable psychiatric illness and other conditions such as known
alcoholism, drug or substance abuse, criminal detention, etc., that affect the
completion of the study procedures
3. Known hypersensitivity to any component of HRS-4642; History of severe allergic
reactions to other monoclonal antibodies/fusion protein drugs; Known history of
severe hypersensitivity to antineoplastic agents in combination
4. Received other major surgery other than diagnosis or biopsy within 28 days before
the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7
days prior to the first dose; Presence of non-healing wounds (severe, non-healing,
or dehiscence), untreated fractures
5. Subjects who are participating in other clinical studies or whose first dose is less
than 4 weeks from the end of the previous clinical study (last dose), or who have 5
half-lives of this investigational drug, whichever is shorter
6. Use of a live attenuated vaccine within 28 days prior to the first dose of study
medication, or anticipated need for a live attenuated vaccine during study treatment
7. Have a history of immunodeficiency, including a positive HIV test, other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation
8. Those who have active pulmonary tuberculosis infection within 1 year before
enrollment, or those who have a history of active pulmonary tuberculosis infection
more than 1 year ago but have not been formally treated
9. Active hepatitis B
10. Presence of clinically significant acute or chronic pancreatitis
11. Poorly controlled or severe cardiovascular and cerebrovascular diseases,
arterior/venous thrombotic events within 6 months prior to study entry
12. Presence of gastrointestinal obstruction or presence of symptoms and signs of
gastrointestinal obstruction within 6 months prior to the start of study treatment,
but screening can be performed if surgical treatment has been performed and the
obstruction has been completely resolved
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200127
Country:
China
Investigator:
Last name:
Liwei Wang
Email:
Principal Investigator
Start date:
July 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06520488
