Solid TumorPhase 1/2NCT07140393
A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
A Phase 1/2 study testing HRS-4508+ Capecitabine, HRS-4508+ Trastuzumab and HRS-4508+ Trastuzumab+ Pertuzumab in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to… 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-4508+ Capecitabine, HRS-4508+ Trastuzumab and HRS-4508+ Trastuzumab+ Pertuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to Oct 2028
- 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
- Age: 18 to 75 years old; Both men and women are welcome;
- The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
- ECOG ratings of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
- Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.
Who cannot join
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- There have been significant severe infections and major surgeries in the past 4 weeks
- Existence of previous or concurrent malignant tumors
- Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Fei Ma
About this study
Official title: An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.
- Conditions
- Solid Tumor
- Being tested
- HRS-4508+ Capecitabine, HRS-4508+ Trastuzumab, HRS-4508+ Trastuzumab+ Pertuzumab, HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel, HRS-4508+ Trastuzumab + Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4508+ CapecitabineDrug
HRS-4508+ Capecitabine
HRS-4508+ TrastuzumabDrug
HRS-4508+ Trastuzumab
HRS-4508+ Trastuzumab+ PertuzumabDrug
HRS-4508+ Trastuzumab+ Pertuzumab
HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxelDrug
HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel
HRS-4508+ Trastuzumab + Nab-paclitaxelDrug
HRS-4508+ Trastuzumab + Nab-paclitaxel
HRS-4508+ Trastuzumab+ CapecitabineDrug
HRS-4508+ Trastuzumab+ Capecitabine
Trastuzumab+ CapecitabineDrug
Trastuzumab+ Capecitabine
Trastuzumab+ PertuzumabDrug
Trastuzumab+ Pertuzumab
HRS-4508+SHR-A1811Drug
HRS-4508+SHR-A1811
| Study group | Role | What they receive |
|---|---|---|
| HRS-4508+ Capecitabine | Experimental | Not described Receives: Drug: HRS-4508+ Capecitabine |
| HRS-4508+ Trastuzumab | Experimental | Not described Receives: Drug: HRS-4508+ Trastuzumab |
| HRS-4508+ Trastuzumab+ Pertuzumab | Experimental | Not described Receives: Drug: HRS-4508+ Trastuzumab+ Pertuzumab |
| HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel | Experimental | Not described Receives: Drug: HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel |
| HRS-4508+ Trastuzumab + Nab-paclitaxel | Experimental | Not described Receives: Drug: HRS-4508+ Trastuzumab + Nab-paclitaxel |
| HRS-4508+ Trastuzumab+ Capecitabine | Experimental | Not described Receives: Drug: HRS-4508+ Trastuzumab+ Capecitabine |
| Trastuzumab+ Capecitabine | Active comparator | Not described Receives: Drug: Trastuzumab+ Capecitabine |
| Trastuzumab+ Pertuzumab | Active comparator | Not described Receives: Drug: Trastuzumab+ Pertuzumab |
| HRS-4508+SHR-A1811 | Experimental | Not described Receives: Drug: HRS-4508+SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRS4508 DLT
Measured: 3 weeks
HRS4508 MTD
Measured: 12 weeks
HRS4508 RP2D
Measured: 12 weeks
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Measured: 2 years
Objective response rate (ORR)
Measured: 1 year
Secondary outcomes (11)
Blood concentrations of HRS-4508
Measured: 15 weeks
Blood concentrations of SHR-A1811
Measured: 9 weeks
Blood concentrations of Capecitabine
Measured: 2 weeks
Objective response rate (ORR)
Measured: 1 year
Best overall efficacy (BOR)
Measured: 1 year
Duration of response (DoR)
Measured: 1 year
Progression free survival (PFS)
Measured: 1 year
Disease control rate (DCR)
Measured: 1 year
Overall survival (OS)
Measured: 2 year
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Measured: 2 years
Blood concentrations of Paclitaxel for Injection
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start28 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07140393
- Sponsor's protocol ID
- HRS-4508-202-BC
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2025
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
- ClinicalTrials.gov ID
- NCT07140393
- Acronym / sponsor ID
- HRS-4508-202-BC
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 24 Aug 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 efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS-4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| HRS-4508+ Capecitabine | Experimental | Drug: HRS-4508+ Capecitabine |
| HRS-4508+ Trastuzumab | Experimental | Drug: HRS-4508+ Trastuzumab |
| HRS-4508+ Trastuzumab+ Pertuzumab | Experimental | Drug: HRS-4508+ Trastuzumab+ Pertuzumab |
| HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel | Experimental | Drug: HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel |
| HRS-4508+ Trastuzumab + Nab-paclitaxel | Experimental | Drug: HRS-4508+ Trastuzumab + Nab-paclitaxel |
| HRS-4508+ Trastuzumab+ Capecitabine | Experimental | Drug: HRS-4508+ Trastuzumab+ Capecitabine |
| Trastuzumab+ Capecitabine | Active comparator | Drug: Trastuzumab+ Capecitabine |
| Trastuzumab+ Pertuzumab | Active comparator | Drug: Trastuzumab+ Pertuzumab |
| HRS-4508+SHR-A1811 | Experimental | Drug: HRS-4508+SHR-A1811 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 to 75 years old; Both men and women are welcome;
- The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
- ECOG ratings of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
Key exclusion criteria (5 listed)
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- There have been significant severe infections and major surgeries in the past 4 weeks
- Existence of previous or concurrent malignant tumors
- Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;
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-4508+ CapecitabineHRS-4508+ Capecitabine | Drug | HRS-4508+ Capecitabine |
| HRS-4508+ TrastuzumabHRS-4508+ Trastuzumab | Drug | HRS-4508+ Trastuzumab |
| HRS-4508+ Trastuzumab+ PertuzumabHRS-4508+ Trastuzumab+ Pertuzumab | Drug | HRS-4508+ Trastuzumab+ Pertuzumab |
| HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxelHRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel | Drug | HRS-4508+ Trastuzumab+ Pertuzumab+ Nab-paclitaxel |
| HRS-4508+ Trastuzumab + Nab-paclitaxelHRS-4508+ Trastuzumab + Nab-paclitaxel | Drug | HRS-4508+ Trastuzumab + Nab-paclitaxel |
| HRS-4508+ Trastuzumab+ CapecitabineHRS-4508+ Trastuzumab+ Capecitabine | Drug | HRS-4508+ Trastuzumab+ Capecitabine |
| Trastuzumab+ CapecitabineTrastuzumab+ Capecitabine | Drug | Trastuzumab+ Capecitabine |
| Trastuzumab+ PertuzumabTrastuzumab+ Pertuzumab | Drug | Trastuzumab+ Pertuzumab |
| HRS-4508+SHR-A1811HRS-4508+SHR-A1811 | Drug | HRS-4508+SHR-A1811 |
Primary outcome
HRS4508 DLT
Time frame: 3 weeks
HRS4508 MTD
Time frame: 12 weeks
HRS4508 RP2D
Time frame: 12 weeks
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 1 year
11 secondary outcomes
Blood concentrations of HRS-4508
Time frame: 15 weeks
Blood concentrations of SHR-A1811
Time frame: 9 weeks
Blood concentrations of Capecitabine
Time frame: 2 weeks
Objective response rate (ORR)
Time frame: 1 year
Best overall efficacy (BOR)
Time frame: 1 year
Duration of response (DoR)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 2 years
Blood concentrations of Paclitaxel for Injection
Time frame: 6 weeks
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 29 Jun 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.
1 site 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-4508+ Capecitabine, HRS-4508+ Trastuzumab and HRS-4508+ Trastuzumab+ Pertuzumab in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 6 inclusion and 5 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jiaman Lin (+86 180 0245 4915, jiaman.lin@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRS4508 DLT (time frame: 3 weeks). 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 29 Jun 2026.