Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06770569

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-30

100

Participants Needed

6

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.

CONDITIONS

Official Title

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients willing to participate, sign informed consent, comply with study, and attend follow-up visits
  • Age 18 years or older, any gender
  • Confirmed advanced malignant tumors by pathology
  • Failure of or no effective standard treatments
  • At least one measurable extracranial target lesion per RECIST v1.1
  • Expected survival greater than 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow and organ function without recent blood transfusion or stimulating factor treatment within 14 days
  • Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before starting and agree to use effective contraception during the study and for one month after last dose
Not Eligible

You will not qualify if you...

  • Cancerous meningitis or untreated central nervous system metastases
  • Severe cardiovascular or cerebrovascular diseases
  • Uncontrolled third-space effusions like massive ascites, pleural or pericardial effusion
  • Current or past idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation or drug-induced pneumonia, or active pneumonia seen on screening CT
  • Arteriovenous thrombosis within 6 months before first dose
  • Severe infection within 4 weeks before first dose
  • Refractory nausea, vomiting, or gastrointestinal disorders affecting oral medication use, including malabsorption syndrome
  • Known HIV infection or AIDS
  • Active hepatitis
  • Scheduled to receive other systemic anti-cancer therapies during the study
  • Known allergies or contraindications to the investigational drug or its components
  • Other conditions judged by the investigator that may affect safety or study data collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

GenesisCare North Shore (Oncology)

Saint Leonards, New South Wales, Australia, 2065

Active, Not Recruiting

2

Macquarie University Hospital

Sydney, New South Wales, Australia, 2109

Active, Not Recruiting

3

John Flynn Private Hospital

Tugun, Queensland, Australia, 4224

Active, Not Recruiting

4

GenesisCare St Andrews

Adelaide, South Australia, Australia, 5000

Active, Not Recruiting

5

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, Australia, 3199

Active, Not Recruiting

6

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

X

Xiaoyu Zhu

CONTACT

Y

Yueling Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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