Phase I Clinical Study of HRS-2189 in the Treatment of Patients With Advanced Malignant Tumors

NCT05851092 | Unknown Phase 1

• 1 other identifier: HRS-2189-I-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (4)

• AEs+SAEs

  from the first drug administration to within 30 days for the last treatment dose

• Dose limited toxicity (DLT) of HRS-2189

  up to 35 days

• Maximum tolerated dose（MTD）of HRS-2189

  up to 35 days

• Recommended Phase II Dose (RP2D) of HRS-2189

  up to 35 days

Secondary Outcomes (14)

• Evaluation of pharmacokinetic parameter of HRS-2189: Cmax

  2 months

• Evaluation of pharmacokinetic parameter of HRS-2189: Tmax

  2 months

• Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t

  2 months

• Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf

  2 months

• Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss

  2 months

Study Arms (1)

HRS-2189 Tablets

EXPERIMENTAL

Drug: HRS-2189 Tablets

Interventions

HRS-2189 Tablets DRUG

HRS-2189 Tablets

HRS-2189 Tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this study, sign an informed consent form, have good compliance, and can cooperate with follow-up
• Age ≥ 18 years old (including boundary value, calculated based on the date of signing informed consent), Male or female
• ECOG score: 0-1
• Expected survival ≥ 12 weeks
• 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
• 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
• Baseline presence of at least one extracranial measurable lesion that meets the RECIST v1.1 standard
• The functional level of important organs is basically normal, meeting the requirements of the scheme
• 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
• 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)
• 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
• 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

You may not qualify if:

• Subjects with cancerous meningitis or untreated central nervous system metastasis
• Uncontrolled pleural, abdominal, and pericardial effusion
• Clinical symptoms or diseases of the heart that are not well controlled
• Arterial/venous thrombotic events occurred within 6 months before the first medication administration
• 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)
• Subjects with congenital or acquired immune dysfunction (such as HIV infected persons); Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Subject has active hepatitis
• 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
• Those who are unable to swallow tablets normally or have gastrointestinal dysfunction that may affect drug absorption according to the judgment of the researcher
• 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
• Pregnant and lactating women, or planning to become pregnant during the study period
• According to the judgment of the researcher, the subject has other factors that may lead to the forced termination of this study

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Central Study Contacts

Xia Zhang

CONTACT

+86-0518-81220121; xia.zhang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: May 26, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 7, 2023

Record last verified: 2023-04

Locations

CN (1)