Advanced Solid TumorsPhase 1NCT06770569
A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors
A Phase 1 study testing HRS-3802 in people with Advanced Solid Tumors, run by Shandong Suncadia Medicine Co., Ltd. at 6 sites in 2 countries.
Trial summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRS-3802
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 21 Jan 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia5 sites
- Active, not recruiting
GenesisCare St Andrews
Adelaide, South Australia, 5000
- Active, not recruiting
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
- Active, not recruiting
GenesisCare North Shore (Oncology)
Saint Leonards, New South Wales, 2065
- Active, not recruiting
Macquarie University Hospital
Sydney, New South Wales, 2109
- Active, not recruiting
John Flynn Private Hospital
Tugun, Queensland, 4224
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe Xu
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- HRS-3802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-3802Drug
HRS-3802
| Study group | Role | What they receive |
|---|---|---|
| HRS-3802 | Experimental | Not described Receives: Drug: HRS-3802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and the severity of adverse events
Measured: Every 4 weeks after treatment initiation (through study completion，an average 5 mouths)
Dose-limiting toxicity (DLT)
Measured: During the first 28-day cycle of HRS-3802 treatment
Maximum tolerated dose (MTD)
Measured: 3 weeks after treatment initiation
Recommended Phase II Dose (RP2D)
Measured: 3 weeks after treatment initiation
Secondary outcomes (3)
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.
Measured: Up to approximately 6 months
Duration of Response (DoR) per RECIST 1.1
Measured: Up to approximately 2 years
Progression-free survival (PFS) per RECIST 1.1
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start21 Jan 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770569
- Sponsor's protocol ID
- HRS-3802-101
- Status last verified
- Mar 2026
- First submitted
- 26 Dec 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06770569
- Acronym / sponsor ID
- HRS-3802-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-3802 monotherapy in patients with malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-3802 | Experimental | Drug: HRS-3802 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-3802HRS-3802 | Drug | HRS-3802 |
Primary outcome
Number of subjects with adverse events and the severity of adverse events
Time frame: Every 4 weeks after treatment initiation (through study completion，an average 5 mouths)
Dose-limiting toxicity (DLT)
Time frame: During the first 28-day cycle of HRS-3802 treatment
Maximum tolerated dose (MTD)
Time frame: 3 weeks after treatment initiation
Recommended Phase II Dose (RP2D)
Time frame: 3 weeks after treatment initiation
3 secondary outcomes
Objective response rate (ORR) - RECIST 1.1
Time frame: Up to approximately 6 months
Duration of Response (DoR) per RECIST 1.1
Time frame: Up to approximately 2 years
Progression-free survival (PFS) per RECIST 1.1
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-3802 in people with Advanced Solid Tumors, run by Shandong Suncadia Medicine Co., Ltd. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu (0518-82342973, xiaoyu.zhu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and the severity of adverse events (time frame: Every 4 weeks after treatment initiation (through study completion，an average 5 mouths)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.