Solid TumorPhase 1/2NCT07229586
A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors
A Phase 1/2 study testing SHR-7367 Injection, SHR-1316 Injection and Paclitaxel for Injection in people with Solid Tumor, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). 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?
- SHR-7367 Injection, SHR-1316 Injection and Paclitaxel for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2025to Dec 2027
- 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
- Be able and willing to provide a written informed consent.
- Age 18-75 years old (inclusive) at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Life expectancy is not less than 12 weeks.
- At least one measurable lesion per RECIST v1.1.
- Adequate organ and marrow function as defined by the protocol.
Who cannot join
- Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
- Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
- Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
- Active HBV/HCV/HIV infection.
- Untreated and/or uncontrolled brain metastases.
- Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, +86-022-23340123, haojihui@tjmuch.com
Jihui Hao
About this study
Official title: A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
- Conditions
- Solid Tumor
- Being tested
- SHR-7367 Injection, SHR-1316 Injection, Paclitaxel for Injection, Gemcitabine Hydrochloride for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7367 InjectionDrug
SHR-7367 injection.
SHR-1316 InjectionDrug
SHR-1316 injection.
Paclitaxel for InjectionDrug
Paclitaxel for injection (Albumin Bound).
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-7367 + SHR-1316 Group | Experimental | SHR-7367 combined with SHR-1316. Receives: Drug: SHR-7367 Injection; Drug: SHR-1316 Injection |
| SHR-7367 + SHR-1316 + AG Group | Experimental | SHR-7367 combined with SHR-1316 and AG. Receives: Drug: SHR-7367 Injection; Drug: SHR-1316 Injection; Drug: Paclitaxel for Injection; Drug: Gemcitabine Hydrochloride for Injection |
| SHR-7367 + AG Group | Experimental | SHR-7367 combined with AG. Receives: Drug: SHR-7367 Injection; Drug: Paclitaxel for Injection; Drug: Gemcitabine Hydrochloride for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
Measured: Up to 28 days.
Stage 1 (IB Period): Adverse events (AEs).
Measured: About 1 year.
Stage 1 (IB Period): Serious adverse events (SAEs).
Measured: About 1 year.
Phase II: Investigator-assessed objective response rate (ORR).
Measured: Assessed every 6 weeks, about 1 year.
Secondary outcomes (5)
Investigator-assessed objective response rate (ORR).
Complete response + Partial response (CR+PR) based on RECIST v1.1.
Measured: Assessed every 6 weeks, about 1 year.
Disease control rate (DCR).
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST v1.1.
Measured: Assessed every 6 weeks, about 1 year.
Duration of response (DoR).
Time from documentation of tumor response to disease progression assessed among patients who had an objective response.
Measured: Assessed every 6 weeks, about 1 year.
Progression Free Survival (PFS).
Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.
Measured: Assessed every 6 weeks, about 1 year.
Incidence and severity of Adverse events (AEs).
Time from C1D1 to the first assessment of disease progression or death, whichever is earlier.
Measured: Assessed approximately once every 1 month, 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 posted17 Nov 2025
- Study start2 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 Shanghai Hengrui Pharmaceutical 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229586
- Sponsor's protocol ID
- HRS-4642-205-01
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT07229586
- Acronym / sponsor ID
- HRS-4642-205-01
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Nov 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.
This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-7367 + SHR-1316 Group | Experimental | Drug: SHR-7367 Injection, Drug: SHR-1316 InjectionSHR-7367 combined with SHR-1316. |
| SHR-7367 + SHR-1316 + AG Group | Experimental | Drug: SHR-7367 Injection, Drug: SHR-1316 Injection, Drug: Paclitaxel for Injection, Drug: Gemcitabine Hydrochloride for InjectionSHR-7367 combined with SHR-1316 and AG. |
| SHR-7367 + AG Group | Experimental | Drug: SHR-7367 Injection, Drug: Paclitaxel for Injection, Drug: Gemcitabine Hydrochloride for InjectionSHR-7367 combined with AG. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able and willing to provide a written informed consent.
- Age 18-75 years old (inclusive) at the time of signing the informed consent form.
- ECOG performance status 0-1.
- Life expectancy is not less than 12 weeks.
- At least one measurable lesion per RECIST v1.1.
Key exclusion criteria (7 listed)
- Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.
- Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.
- Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).
- Surgery or chemotherapy within 4 weeks of the first dose of study treatment.
- Active HBV/HCV/HIV infection.
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 |
|---|---|---|
| SHR-7367 InjectionSHR-7367 injection. | Drug | SHR-7367 + AG Group, SHR-7367 + SHR-1316 + AG Group, SHR-7367 + SHR-1316 Group |
| SHR-1316 InjectionSHR-1316 injection. | Drug | SHR-7367 + SHR-1316 + AG Group, SHR-7367 + SHR-1316 Group |
| Paclitaxel for InjectionPaclitaxel for injection (Albumin Bound). | Drug | SHR-7367 + AG Group, SHR-7367 + SHR-1316 + AG Group |
| Gemcitabine Hydrochloride for InjectionGemcitabine Hydrochloride for injection. | Drug | SHR-7367 + AG Group, SHR-7367 + SHR-1316 + AG Group |
Primary outcome
Stage 1 (IB Period): Dose-limiting toxicity (DLT).
Time frame: Up to 28 days.
Stage 1 (IB Period): Adverse events (AEs).
Time frame: About 1 year.
Stage 1 (IB Period): Serious adverse events (SAEs).
Time frame: About 1 year.
Phase II: Investigator-assessed objective response rate (ORR).
Time frame: Assessed every 6 weeks, about 1 year.
5 secondary outcomes
Investigator-assessed objective response rate (ORR).
Time frame: Assessed every 6 weeks, about 1 year.
Disease control rate (DCR).
Time frame: Assessed every 6 weeks, about 1 year.
Duration of response (DoR).
Time frame: Assessed every 6 weeks, about 1 year.
Progression Free Survival (PFS).
Time frame: Assessed every 6 weeks, about 1 year.
Incidence and severity of Adverse events (AEs).
Time frame: Assessed approximately once every 1 month, 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 19 Dec 2025.
- 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 SHR-7367 Injection, SHR-1316 Injection and Paclitaxel for Injection in people with Solid Tumor, run by Shanghai Hengrui Pharmaceutical 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 7 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 19 Dec 2025. 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 Botao Zhu (+86-0518-82342973, botao.zhu.bz19@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 (IB Period): Dose-limiting toxicity (DLT). (time frame: Up to 28 days.). 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 19 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.