Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06770569




Registration number
NCT06770569
Ethics application status
Date submitted
26/12/2024
Date registered
13/01/2025
Date last updated
19/08/2025

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors
Scientific title
Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors: a Single-arm, Open, Multicenter Phase I Study
Secondary ID [1] 0 0
HRS-3802-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-3802

Experimental: HRS-3802 -


Treatment: Drugs: HRS-3802
HRS-3802
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events and the severity of adverse events
Timepoint [1] 0 0
every 4 weeks after treatment initiation(through study completion,an average 5mouthes)
Primary outcome [2] 0 0
DLT(Dose-limiting toxicity)
Timepoint [2] 0 0
during the first 28-day cycle of HRS-3802 treatment
Primary outcome [3] 0 0
MTD(Maximum tolerated dose)
Timepoint [3] 0 0
3 weeks after treatment initiation
Primary outcome [4] 0 0
RP2D(Recommended Phase II Dose)
Timepoint [4] 0 0
3 weeks after treatment initiation
Secondary outcome [1] 0 0
ORR(Objective response rate (ORR) - RECIST 1.1
Timepoint [1] 0 0
Up to approximately 6 months
Secondary outcome [2] 0 0
DoR(Duration of Response (DoR)Duration of Response (DoR) per RECIST 1.1)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
PFS-Progression-free survival(PFS) PFS per RECIST 1.1
Timepoint [3] 0 0
Up to approximately 2 years]

Eligibility
Key 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:
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GenesisCare North Shore (Oncology) - Saint Leonards
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
John Flynn Private Hospital - Tugun
Recruitment hospital [4] 0 0
GenesisCare St Andrews - Adelaide
Recruitment hospital [5] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
4224 - Tugun
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing Municipality

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shandong Suncadia Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xiaoyu Zhu
Address 0 0
Country 0 0
Phone 0 0
0518-82342973
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06770569