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Trial Title:
Phase I Clinical Study of HRS-2189 in the Treatment of Patients With Advanced Malignant Tumors
NCT ID:
NCT05851092
Condition:
Advanced Malignant Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
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-2189 Tablets
Description:
HRS-2189 Tablets
Arm group label:
HRS-2189 Tablets
Summary:
This study is a multi center, open label, dose increasing/dose expanding/efficacy
expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK
characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in
patients with advanced malignant solid tumors. This study was divided into three stages:
dose escalation, dose expansion, and efficacy expansion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Volunteer to participate in this study, sign an informed consent form, have good
compliance, and can cooperate with follow-up
2. Age ≥ 18 years old (including boundary value, calculated based on the date of
signing informed consent), Male or female
3. ECOG score: 0-1
4. Expected survival ≥ 12 weeks
5. Local recurrent or metastatic advanced malignant solid tumor confirmed by
histopathology or cytopathology and not resectable, and currently fails to undergo
standard treatment or has no standard treatment plan
6. If enrolled in ER positive and HER2 negative female breast cancer subjects, they
need to meet the criteria defined in the guidelines of the American Association of
Clinical Oncology/American College of Pathologists
7. Baseline presence of at least one extracranial measurable lesion that meets the
RECIST v1.1 standard
8. The functional level of important organs is basically normal, meeting the
requirements of the scheme
9. Previous treatment: Before the first medication in this study, the interval between
receiving nitrosourea or mitomycin C ≥ 6 weeks; Receiving cytotoxic drugs, endocrine
therapy, immunotherapy, targeted therapy, surgical interval (except puncture biopsy
or PICC catheterization or PORT infusion port catheterization) or other clinical
studies with the last medication ≥ 4 weeks; Interval from the end of radiotherapy ≥
2 weeks
10. Adverse events caused by other treatments for the subject returned to a severity
level of NCI-CTCAE V5.0 ≤ 1 (excluding hair loss and other adverse events judged
tolerable by the investigator)
11. Female subjects with fertility must agree to use highly effective contraception
during the study treatment period and within 7 months after the last medication;
Male subjects must agree to use highly effective contraception during the study
treatment period and 4 months after the last medication; Female subjects with
fertility must have a negative serum HCG test within 7 days before the first
medication in the study, and must be in non lactation. If the serum HCG is weakly
positive, it is necessary for the researcher to evaluate and judge it as a non
pregnant state, and urine HCG should be tested before medication, with a negative
result
12. Volunteer to participate in this clinical trial, willing and able to follow the
procedures related to clinical visits and research, understand the research
procedures, and have signed informed consent
Exclusion Criteria:
1. Subjects with cancerous meningitis or untreated central nervous system metastasis
2. Uncontrolled pleural, abdominal, and pericardial effusion
3. Clinical symptoms or diseases of the heart that are not well controlled
4. Arterial/venous thrombotic events occurred within 6 months before the first
medication administration
5. Active infection or unexplained fever>38.5 ° C occurred within 4 weeks before or on
the day of the first medication (subjects with tumor fever are judged by the
investigator to be included in the study)
6. Subjects with congenital or acquired immune dysfunction (such as HIV infected
persons); Known history of allogeneic organ transplantation or allogeneic
hematopoietic stem cell transplantation
7. Subject has active hepatitis
8. Subjects had other malignant tumors within the past 3 years, except for fully
treated basal or squamous cell skin cancer or cervical carcinoma in situ
9. Those who are unable to swallow tablets normally or have gastrointestinal
dysfunction that may affect drug absorption according to the judgment of the
researcher
10. Patients participating in the QT/QTc study have used any medication that has the
risk of prolonging the QT/QTc interval or causing torsade de pointe (TdP) within 4
weeks before the first medication, have a previous history of congenital QT interval
prolongation syndrome or a family history of QT interval prolongation, have an
implanted pacemaker or automatic implantable cardioverter defibrillator, and cannot
correct electrolyte disturbances that affect the QT/QTc study
11. Pregnant and lactating women, or planning to become pregnant during the study period
12. According to the judgment of the researcher, the subject has other factors that may
lead to the forced termination of this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Investigator:
Last name:
Qingyuan Zhang
Email:
Principal Investigator
Start date:
May 26, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shandong Suncadia Medicine Co., Ltd.
Agency class:
Industry
Source:
Shandong Suncadia Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851092