Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

Last updated: February 24, 2025
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

HRS-3802

Clinical Study ID

NCT06770569
HRS-3802-101
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be willing to participate in the study, sign the informed consentform, 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 transfusionor hematopoietic stimulating factor treatment within 14 days):

  9. Female subjects of childbearing age must undergo a serum pregnancy test within 7days before starting the study medication, and the result is negative, and arewilling to use a medically approved high-efficiency contraception during the studyperiod and within 1 months after the last administration of the study drug Measures:

Exclusion

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 othermethods (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 showedactive 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 thataffect the use of oral medications: including malabsorption syndrome

  8. Known history of human immunodeficiency virus (HIV) seropositive status or acquiredimmunodeficiency syndrome (AIDS)

  9. Subjects had active hepatitis;

  10. Subjects were scheduled to receive other systemic antitumor therapies during thestudy period;

  11. Known allergies and contraindications to the investigational drug or any of itscomponents;

  12. Other factors as judged by the investigator that may lead to the termination of thestudy, such as other serious diseases, serious laboratory test abnormalities, orfamily or social factors that could affect the safety of the subject, or thecollection of study data and samples.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: HRS-3802
Phase: 1
Study Start date:
January 21, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

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