Solid TumorPhase 1/2NCT07446153
A Clinical Study of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
A Phase 1/2 study testing HRS-8364 Tablet in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HRS-8364 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesChina
- Study dates
- 19 Mar 2026to Dec 2029
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily joining this study, signing an informed consent form, good compliance, and able to cooperate with follow-up.
- Age range: 18-75 years old (including boundary values), both males and females are eligible.
- Monotherapy dose escalation stage: advanced solid tumors diagnosed by cytology or histology, which have failed standard treatment or are intolerant to previous standard treatment or have no standard treatment.
- Monotherapy dose expansion stage: advanced solid tumors diagnosed by cytology or histology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment; The combined dose expansion phase allows for the inclusion of individuals who have not received prior treatment with immuno checkpoint inhibitors (ICIs).
- Efficacy expansion of monotherapy: advanced solid tumors diagnosed by histopathology or cytology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment.
- At least one measurable lesion that meets the RECIST v1.1 criteria.
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- ECOG PS score: 0 to 1.
- Expected survival ≥ 12 weeks.
- Female subjects with reproductive ability and male subjects with partners who are reproductive women must agree to use efficient contraception during the trial period and within 30 days after the last dose of HRS-8364 (whichever comes later), have no fertility plan, and avoid donating eggs/sperm; Female subjects with fertility must have a negative blood pregnancy test within 7 days prior to the first administration and must be non-lactating.
Who cannot join
- Untreated brain metastases; Or accompanied by meningeal metastasis, spinal cord compression, etc.
- Large blood vessels invasion confirmed by imaging, or the subject's tumor has a high possibility of invading important blood vessels and causing fatal bleeding during treatment judged by researchers.
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion accompanied by clinical symptoms.
- Severe bone damage caused by tumor bone metastasis, including uncontrolled severe bone pain, pathological fractures in important areas that have occurred or are expected to occur in the past 6 months, and spinal cord compression. Subjects who require analgesic medication must have a stable analgesic treatment plan in place at the time of entry into the study.
- Other malignant tumors in the past 5 years or at the same time.
- Major arterial/venous thrombotic events within 6 months prior to the first use of medication, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction (excluding asymptomatic lacunar cerebral infarction)), deep vein thrombosis (excluding asymptomatic and non anticoagulant intramuscular vein thrombosis), and pulmonary embolism.
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- Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid systemic therapy (such as radiation pneumonitis); Currently, individuals with active pneumonia or confirmed severe pulmonary ventilation dysfunction through lung function tests.
- Individuals with active pulmonary tuberculosis. Individuals who have undergone sufficient treatment and have stopped anti tuberculosis treatment for at least 3 months prior to their first medication can be enrolled in the study.
- Known to have a positive history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Known to have active viral hepatitis.
- Unable to swallow pills normally or experiencing gastrointestinal dysfunction, which may affect drug absorption according to researchers' assessment.
- Individuals who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to their first medication use.
- According to the researchers' assessment, there are other factors that may affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug use, drug abuse, other serious illnesses (including mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect medication safety.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun-Yat-Sen University
Guangzhou, Guangdong, 510655
Xiaojian Wu, +86-020-85655897, 13760608396@163.com
Xiaojian Wu
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Jingdong Zhang, +86-024-81916599, 13804027878@163.com
Jingdong Zhang
About this study
Official title: An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.
- Conditions
- Solid Tumor
- Being tested
- HRS-8364 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8364 TabletDrug
HRS-8364 tablet.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8364 Group | Experimental | HRS-8364 in different doses. Receives: Drug: HRS-8364 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT)
Measured: Post-dose at Day 1 to Day 21.
The Maximum Tolerated Dose (MTD)
Measured: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Measured: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Measured: From signing the informed consent form to safety follow-up completed, about 1 year.
Objective Response Rate (ORR)
Measured: From the first administration to the end of treatment visit, about 1 year.
Secondary outcomes (7)
Maximum Concentration of HRS-8364 (Cmax)
Measured: Day 1 pre-dose to the end of treatment visit, about 1 year.
Time to maximum plasma concentration (Tmax)
Measured: Day 1 pre-dose to the end of treatment visit, about 1 year.
Area under the concentration versus time curve of HRS-8364 from time zero to time t (AUC0-t).
Measured: Day 1 pre-dose to the end of treatment visit, about 1 year.
Bioaccumulation of HRS-8364 in postprandial relative fasting state.
Measured: Cycle 0 Day1 pre-dose to Cycle 1 Day 3, about 6 days.
Duration of relief (DOR).
Measured: From the first administration to the end of treatment visit, about 1 year.
Disease Control Rate (DCR).
Measured: From the first administration to the end of treatment visit, about 1 year.
Progression-free survival (PFS).
Measured: From the first administration to the end of treatment visit, about 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start19 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label ,multicenter, phase I/II clinical study.
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446153
- Sponsor's protocol ID
- HRS-8364-101
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Apr 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-8364 in the Treatment of Advanced Solid Tumor Subjects
- ClinicalTrials.gov ID
- NCT07446153
- Acronym / sponsor ID
- HRS-8364-101
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (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.
This study is an open, multicenter, Phase I/II clinical trial, divided into three stages: dose escalation, dose expansion and efficacy expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label ,multicenter, phase I/II clinical study.
| Arm | Type | Receives |
|---|---|---|
| HRS-8364 Group | Experimental | Drug: HRS-8364 TabletHRS-8364 in different doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily joining this study, signing an informed consent form, good compliance, and able to cooperate with follow-up.
- Age range: 18-75 years old (including boundary values), both males and females are eligible.
- Monotherapy dose escalation stage: advanced solid tumors diagnosed by cytology or histology, which have failed standard treatment or are intolerant to previous standard treatment or have no standard treatment.
- Monotherapy dose expansion stage: advanced solid tumors diagnosed by cytology or histology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment; The combined dose expansion phase allows for the inclusion of individuals who have not received prior treatment with immuno checkpoint inhibitors (ICIs).
- Efficacy expansion of monotherapy: advanced solid tumors diagnosed by histopathology or cytology; with other systemic treatments during the recurrence or metastasis stage, and disease progression during or after treatment.
Key exclusion criteria (12 listed)
- Untreated brain metastases; Or accompanied by meningeal metastasis, spinal cord compression, etc.
- Large blood vessels invasion confirmed by imaging, or the subject's tumor has a high possibility of invading important blood vessels and causing fatal bleeding during treatment judged by researchers.
- Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion accompanied by clinical symptoms.
- Severe bone damage caused by tumor bone metastasis, including uncontrolled severe bone pain, pathological fractures in important areas that have occurred or are expected to occur in the past 6 months, and spinal cord compression. Subjects who require analgesic medication must have a stable analgesic treatment plan in place at the time of entry into the study.
- Other malignant tumors in the past 5 years or at the same time.
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-8364 TabletHRS-8364 tablet. | Drug | HRS-8364 Group |
Primary outcome
The Dose-Limiting Toxicity (DLT)
Time frame: Post-dose at Day 1 to Day 21.
The Maximum Tolerated Dose (MTD)
Time frame: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Time frame: Post-dose at Day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Time frame: From signing the informed consent form to safety follow-up completed, about 1 year.
Objective Response Rate (ORR)
Time frame: From the first administration to the end of treatment visit, about 1 year.
7 secondary outcomes
Maximum Concentration of HRS-8364 (Cmax)
Time frame: Day 1 pre-dose to the end of treatment visit, about 1 year.
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 pre-dose to the end of treatment visit, about 1 year.
Area under the concentration versus time curve of HRS-8364 from time zero to time t (AUC0-t).
Time frame: Day 1 pre-dose to the end of treatment visit, about 1 year.
Bioaccumulation of HRS-8364 in postprandial relative fasting state.
Time frame: Cycle 0 Day1 pre-dose to Cycle 1 Day 3, about 6 days.
Duration of relief (DOR).
Time frame: From the first administration to the end of treatment visit, about 1 year.
Disease Control Rate (DCR).
Time frame: From the first administration to the end of treatment visit, about 1 year.
Progression-free survival (PFS).
Time frame: From the first administration to the end of treatment visit, about 1 year.
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 3 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-8364 Tablet in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Cong Wen (+86-021-61053363, cong.wen@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dose-Limiting Toxicity (DLT) (time frame: Post-dose at Day 1 to Day 21.). The study lists 5 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 3 Apr 2026.