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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HRS-3802

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu; Phone Number: 0518-82342973; Email: xiaoyu.zhu@hengrui.com
• Study Contact Backup: Name: Yueling Wang; Phone Number: 021-60453139; Email: yueling.wang@hengrui.com

Study Locations

• Australia
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • Active, not recruiting
      • GenesisCare North Shore (Oncology)
    • Sydney, New South Wales, Australia, 2109
      • Active, not recruiting
      • Macquarie University Hospital
  • Queensland
    • Tugun, Queensland, Australia, 4224
      • Active, not recruiting
      • John Flynn Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Active, not recruiting
      • Genesiscare St Andrews
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Active, not recruiting
      • Peninsula and South Eastern Haematology & Oncology Group
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Principal Investigator: Binghe Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-3802	Drug: HRS-3802; HRS-3802

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events and the severity of adverse events	Every 4 weeks after treatment initiation (through study completion，an average 5 mouths)
Dose-limiting toxicity (DLT)	During the first 28-day cycle of HRS-3802 treatment
Maximum tolerated dose (MTD)	3 weeks after treatment initiation
Recommended Phase II Dose (RP2D)	3 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) - RECIST 1.1	ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1.	Up to approximately 6 months
Duration of Response (DoR) per RECIST 1.1		Up to approximately 2 years
Progression-free survival (PFS) per RECIST 1.1		Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HRS-3802-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No