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Trial Title:
A Phase I Clinical Study of the Safety， Tolerability，Pharmacokinetics, and Initial Efficacy of HRS-6209 Monotherapy in Patients With Advanced Solid Tumors
NCT ID:
NCT05781048
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
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-6209
Description:
HRS-6209
Arm group label:
HRS-6209
Summary:
The study is being conducted to evaluate the efficacy, andsafety of HRS-6209in subjects
with advanced solid tumors.To explore the reasonable dosage of HRS-6209.This study also
preliminarily evaluated the efficacy of HRS-6209 in patients with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be willing to participate in the study, sign the informed consent
form, have good compliance, and cooperate with follow-up visits.
2. Aged 18-80 years, male or female
3. Patients with advanced malignant tumors confirmed pathologically;
4. Failure of adequate standard treatment, or no effective standard treatment;
5. Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1
;
6. The expected survival period is more than 12 weeks;
7. The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
8. Have sufficient bone marrow and organ function (have not received blood transfusion
or hematopoietic stimulating factor treatment within 14 days)；
9. Female subjects of childbearing age must undergo a serum pregnancy test within 3
days before starting the study medication, and the result is negative, and are
willing to use a medically approved high-efficiency contraception during the study
period and within 6 months after the last administration of the study drug Measures:
For male subjects whose partners are females of childbearing age, they should be
surgically sterilized, or agree to use effective methods of contraception during the
study period and within 3 months after the last study administration;
Exclusion Criteria:
1. Subjects with a history of malignant tumors, except patients with cutaneous basal
cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or
cervical carcinoma in situ who have undergone possible curative treatment and did
not have disease recurrence within 3 years since starting the treatment；
2. Subjects had cancerous meningitis or untreated central nervous system metastases
3. Subjects experienced intestinal obstruction and gastrointestinal perforation within
3 months prior to initial medication
4. There is third-space effusion that cannot be controlled by drainage and other
methods (such as massive ascites, pleural effusion, pericardial effusion)；
5. Subjects had clinical cardiac symptoms or disease that was not well controlled
within 6 months prior to initial medication
6. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed
active pneumonia；
7. Arteriovenous thrombosis occurred within 6 months prior to the first dose
8. Severe infection occurred within 4 weeks prior to initial administration
9. During the screening period/before the first administration, fever of unknown
origin> 38.5°C
10. Known history of human immunodeficiency virus (HIV) seropositive status or acquired
immunodeficiency syndrome (AIDS)
11. Subjects had active hepatitis；
12. Subjects received live attenuated vaccine within 4 weeks or planned for the study
period prior to initial administration；
13. Subjects were scheduled to receive other systemic antitumor therapies during the
study period；
14. Participated in other clinical studies within 4 weeks before starting the study drug
treatment；
15. Subjects were unable to swallow pills or capsules normally, or had gastrointestinal
abnormalities that the researchers determined might affect drug absorption；
16. Other factors as judged by the investigator that may lead to the termination of the
study, such as other serious diseases, serious laboratory test abnormalities, or
family or social factors that could affect the safety of the subject, or the
collection of study data and samples.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2023
Completion date:
December 30, 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/NCT05781048
