HRS-4508 as a first-in-human treatment in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of HRS-4508 administered as a monotherapy in adults with advanced or metastatic solid tumors. The study aims to determine a reasonable dosage and gather initial signals of efficacy while monitoring for adverse effects. Eligible participants are adults 18-75 with measurable disease, adequate organ function, and a performance status of 0-1. Key assessments include safety labs, imaging per RECIST v1.1, and pharmacokinetic profiling. The trial is led by Jiangsu HengRui Medicine Co., Ltd., at Cancer Hospital Chinese Academy of Medical Sciences in Beijing, with enrollment limited to this site.

Why it matters

Who can join: the full rules

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 18-75 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):

   ANC≥1.5 ×10e9/L; PLT≥100 × 10e9/L; Hb≥ 90 g/L; Cr）≤1.5 × times the upper limit of normal (ULN) or Clcr≥ 60 mL/min; LVEF≥50%; TBIL≤1.5 × times the upper limit of normal (ULN) ; ALT and AST ≤3×times the upper limit of normal (ULN)（Patients with liver metastasis, ≤5×ULN）; International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
9. Female subjects of childbearing age must undergo a serum pregnancy test within 7 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 1 months after the last administration of the study drug Measures.

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 had severe cardiovascular and cerebrovascular diseases.
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 or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug pneumonia, or CT during screening showed active pneumonia.
6. Arteriovenous thrombosis occurred within 6 months prior to the first dose.
7. Severe infection occurred within 4 weeks prior to initial administration.
8. Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome.
9. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS).
10. Subjects had active hepatitis.
11. Subjects were scheduled to receive other systemic antitumor therapies during the study period.
12. Known allergies and contraindications to the investigational drug or any of its components.
13. 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.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaoyu Zhu
• Email: xiaoyu.zhu@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.