Testing HRS-2189 for advanced malignant tumors

A Single Arm, Open, Multicenter Phase I Clinical Study on the Safety, Tolerance, and Pharmacokinetics of HRS-2189 Single Drug in Patients With Advanced Malignant Solid Tumors

This study is testing a new treatment called HRS-2189 for people with advanced solid tumors to see if it can help them when other treatments have failed.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (industry)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT05851092 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of HRS-2189, a new treatment for patients with advanced malignant solid tumors. It is structured in three stages: dose escalation, dose expansion, and efficacy expansion, allowing researchers to assess how well the drug works and its pharmacokinetics. Participants will receive HRS-2189 tablets and will be monitored for their response to the treatment. The study aims to provide insights into the drug's potential as a therapeutic option for patients who have exhausted standard treatment options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced malignant solid tumors that are not resectable and have failed standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced malignant tumors who currently have limited treatment alternatives.

How similar studies have performed: While this approach is not widely tested, similar studies targeting advanced malignant tumors have shown promise in evaluating new treatments.

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

Where this trial is running

Harbin, Heilongjiang

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)

Study contacts

• Study coordinator: Xia Zhang

Conditions: Advanced Malignant Tumor