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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05851092
Other study ID # HRS-2189-I-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 26, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source Shandong Suncadia Medicine Co., Ltd.
Contact Xia Zhang
Phone +86-0518-81220121
Email xia.zhang@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HRS-2189 Tablets
HRS-2189 Tablets

Locations

Country Name City State
China Harbin Medical University Cancer Hospital Harbin Heilongjiang

Sponsors (1)

Lead Sponsor Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary AEs+SAEs from the first drug administration to within 30 days for the last treatment dose
Primary Dose limited toxicity (DLT) of HRS-2189 up to 35 days
Primary Maximum tolerated dose(MTD)of HRS-2189 up to 35 days
Primary Recommended Phase II Dose (RP2D) of HRS-2189 up to 35 days
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Cmax 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Tmax 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Tmax,ss 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Cmin,ss 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: AUCss 2 months
Secondary Evaluation of pharmacokinetic parameter of HRS-2189: Rac 2 months
Secondary Bioavailability of HRS-2189 on an empty stomach and after meals up to 9 days
Secondary Objective Response Rate (ORR) Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI every 8 weeks since Day 8 administration,an average of 1 year
Secondary Duration of response (DoR) Time from documentation of tumor response to disease progression assessed among patients who had an objective response every 8 weeks since Day 8 administration,an average of 1 year
Secondary Disease control rate (DCR) Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 every 8 weeks since Day 8 administration,an average of 1 year
Secondary Progression free survival(PFS) The time from enrollment to the progression of tumors (in any aspect) or death (for any reason) every 8 weeks since Day 8 administration,an average of 1 year
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