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

NCT06770569 | Recruiting Phase 1

• 1 other identifier: HRS-3802-101
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Objective response rate (ORR) - 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

Study Arms (1)

HRS-3802

EXPERIMENTAL

Drug: HRS-3802

Interventions

HRS-3802 DRUG

HRS-3802

HRS-3802

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits;
• Age ≥18 years, male or female;
• Patients with advanced malignant tumors confirmed pathologically;
• Failure of adequate standard treatment, or no effective standard treatment;
• Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1;
• The expected survival period is more than 12 weeks;
• The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
• Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days);
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (6)

GenesisCare North Shore (Oncology)

Saint Leonards, New South Wales, 2065, Australia

ACTIVE NOT RECRUITING

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

ACTIVE NOT RECRUITING

John Flynn Private Hospital

Tugun, Queensland, 4224, Australia

ACTIVE NOT RECRUITING

GenesisCare St Andrews

Adelaide, South Australia, 5000, Australia

ACTIVE NOT RECRUITING

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Victoria, 3199, Australia

ACTIVE NOT RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Central Study Contacts

Xiaoyu Zhu

CONTACT

0518-82342973; xiaoyu.zhu@hengrui.com

Yueling Wang

CONTACT

021-60453139; yueling.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 13, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

AU (5); CN (1)