Evaluating the safety and tolerability of HRS-3802 in patients with advanced solid tumors

A Single-arm, Open-Label, Multi-center Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

This study is testing a new drug called HRS-3802 to see if it is safe and tolerable for people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 6 sites (Saint Leonards, New South Wales and 5 other locations)
• Trial ID: NCT06770569 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and pharmacokinetics of HRS-3802 as a monotherapy in patients diagnosed with advanced malignant solid tumors. Participants will receive HRS-3802 and will be monitored for adverse effects and overall health outcomes. The study will include patients who have not responded to standard treatments or for whom no effective standard treatment exists. The evaluation will focus on measurable target lesions to determine the drug's effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced malignant tumors that have not responded to 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 provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in assessing new therapies for advanced solid tumors.

Eligibility criteria

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. Age ≥18 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);
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 had cancerous meningitis or untreated central nervous system metastases;
2. Subjects had severe cardiovascular and cerebrovascular diseases;
3. There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion);
4. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia;
5. Arteriovenous thrombosis occurred within 6 months prior to the first dose;
6. Severe infection occurred within 4 weeks prior to initial administration;
7. Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome;
8. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS);
9. Subjects had active hepatitis;
10. Subjects were scheduled to receive other systemic antitumor therapies during the study period;
11. Known allergies and contraindications to the investigational drug or any of its components;
12. 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 this trial is running

Saint Leonards, New South Wales and 5 other locations

• GenesisCare North Shore (Oncology) — Saint Leonards, New South Wales, Australia (Active_not_recruiting)
• Macquarie University Hospital — Sydney, New South Wales, Australia (Active_not_recruiting)
• John Flynn Private Hospital — Tugun, Queensland, Australia (Active_not_recruiting)
• GenesisCare St Andrews — Adelaide, South Australia, Australia (Active_not_recruiting)
• Peninsula and South Eastern Haematology & Oncology Group — Frankston, Victoria, Australia (Active_not_recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyu Zhu

Conditions Advanced Solid Tumors