To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation
NCT ID:
NCT06385678
Condition:
Advanced KRAS G12D Mutant Solid Tumors
Conditions: Official terms:
Neoplasms
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-4642
Description:
administrated per dose level in which the patients are assigned
Arm group label:
Arm 1
Arm group label:
Arm 2
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
administrated per dose level in which the patients are assigned
Arm group label:
Arm 1
Intervention type:
Drug
Intervention name:
SHR-A1921
Description:
administrated per dose level in which the patients are assigned
Arm group label:
Arm 2
Intervention type:
Drug
Intervention name:
Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection
Description:
administered as prescribed by the investigator.
Arm group label:
Arm 1
Summary:
The study is being conducted to evaluate the safety, tolerability, and efficacy of
HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors
harboring KRAS G12D mutation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must voluntarily agree to participate in the trial and sign a written
informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 weeks.
5. With unresectable locally advanced or metastatic solid tumors harbouring with KRAS
G12D mutation confirmed by central laboratory testing.
6. Need to provided tumor tissue samples for genetic testing.
7. Have at least one measurable lesion according to RECIST1.1, and the dose-escalation
phase allows no measurable lesion.
8. Adequate laboratory parameters during the screening period.
Exclusion Criteria:
1. Accompanied by untreated or active central nervous system (CNS) metastases. Subjects
with a history or current history of meningeal metastasis.
2. Systemic antitumor therapy was received 4 weeks before the start of the study.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Toxicity and/or complications from previous interventions did not return to
NCI-CTCAE level ≤1 or exclusion criteria.
5. Subjects with known or suspected interstitial pneumonia.
6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or
higher pleural effusion or pericardial effusion.
7. Have poorly controlled or severe cardiovascular disease.
8. Subjects with active hepatitis B or active hepatitis C.
9. A history of immunodeficiency, including a positive HIV test, other acquired or
congenital immunodeficiency disorders, or a history of organ transplantation.
10. The presence of uncontrolled mental illness and other conditions known to affect the
completion of the study process, such as alcohol, drug or substance abuse, and
criminal detention.
11. Any other factors that may increase the risk of participating in the study,
interfere with the study results, or make participation in the study inappropriate
as judged by investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Start date:
July 5, 2024
Completion date:
August 2026
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/NCT06385678
