Advanced Solid TumorPhase 1NCT07380334
A Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 in Patients With Advanced Solid Tumors
A Phase 1 study testing SHR-1049 Injection in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, open label, dose exploration/efficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR-1049 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2026to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;
- Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;
- Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;
- Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;
- Able to provide sufficient fresh or archived tumor tissue specimens for third-party central laboratories designated by the sponsor to test expression levels; For participants who are unable to provide tumor tissue samples, the decision to enroll will be made after joint evaluation by the researchers and the sponsor;
- At least one measurable lesion that meets RECIST v1.1 criteria; Lesions that have undergone local treatment, if there is clear evidence of significant progression after treatment, can be selected as target lesions;
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- ECOG PS score: 0 to 1;
- Expected survival period ≥ 12 weeks;
- The function of important organs meets the requirements;
- Female participants with fertility must have a negative serum HCG test within 7 days prior to their first medication and must be non lactating; Female participants with fertility must agree to use contraception and avoid egg donation for a period of 7 months from the signing of the informed consent form until the last administration of the investigational drug; Male participants whose partners are fertile women must agree to contraception and avoid donating sperm for a period of 4 months from the signing of the informed consent form until the last administration of the investigational drug.
Who cannot join
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;
- Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;
- Previous or concurrent presence of other malignant tumors;
- Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;
- Interstitial pneumonia/interstitial lung disease, non infectious pneumonia (such as radiation pneumonitis) that previously required steroid treatment; Currently present or suspected of having interstitial pneumonia/interstitial lung disease, non infectious pneumonia, or other active pneumonia; Severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other lung damage occurred within 6 months prior to the first use of medication; Individuals with active pulmonary tuberculosis;
- Accompanied by poorly controlled or severe cardiovascular disease;
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- Within one month prior to the first medication, there has been a bleeding event with NCI-CTCAE v5.0 grade ≥ 2;
- Those who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess within 3 months before the first medication;
- Symptoms and signs of gastrointestinal obstruction or gastrointestinal obstruction within 3 months prior to the first use of medication;
- Participants who have experienced a severe infection within one month prior to their first medication;
- History of immunodeficiency, including HIV test positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Participants known to have active hepatitis or active hepatitis C;
- Patients who have previously undergone surgery (excluding diagnostic surgery), radiotherapy, local treatment, chemotherapy, macromolecular targeted therapy, anti-tumor immunotherapy, and have completed treatment (last medication) less than 4 weeks after the first medication; Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) with less than 5 half lives or 4 weeks (whichever is shorter) between the last dose and the first dose;
- Previously received drug treatment with the same mechanism as the experimental drug;
- According to NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor therapy has not yet recovered to ≤ grade 1;
- Individuals known to be allergic to any component or other antibody drugs of SHR-1049 product;
- Those who have received attenuated live vaccine within 4 weeks before the first administration or are likely to receive attenuated live vaccine during treatment and within 60 days after the last administration;
- According to the researcher's judgment, there are other factors that may affect the research results or force the termination of this study midway.
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
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Tingbo Liang, +86-0571-87236688, liangtingbo@zju.edu.cn
Xueli Bai, +86-0571-87236857, shirleybai@zju.edu.cn
About this study
Official title: An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 Injection in Patients With Advanced Solid Tumors
This study is a multicenter, open label, dose exploration/efficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-1049 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1049 InjectionDrug
SHR-1049 injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1049 Group - Queue 1 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
| SHR-1049 Group - Queue 2 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
| SHR-1049 Group - Queue 3 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
| SHR-1049 Group - Queue 4 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
| SHR-1049 Group - Queue 5 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
| SHR-1049 Group - Queue 6 | Experimental | Specified dose on specified days. Receives: Drug: SHR-1049 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of dose-limiting toxicity (DLT).
The first dosing cycle after each subject's enrollment is the DLT observation period.
Measured: Expected results within one year.
Adverse events (AEs).
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Measured: Approximately 12 months after the last patient enrolled.
Serious adverse events (SAEs).
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Measured: Approximately 12 months after the last patient enrolled.
Maximum tolerated dose (MTD).
Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.
Measured: Plan to obtain results within 10 months of the first dose ramp up.
Recommended dose for phase II clinical study (RP2D).
Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.
Measured: Plan to obtain results within 20 months of the first dose ramp up.
Secondary outcomes (7)
Pharmacokinetics (PK) indicator - Blood drug concentration.
The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The PK evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.
Measured: The plan is to complete all evaluations within 2 years.
Immunogenic indicator - Anti-drug antibody (ADA) levels.
The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The ADA evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.
Measured: The plan is to complete all evaluations within 2 years.
Effectiveness indicator - Researchers evaluated objective response rate (ORR).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Measured: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated duration of response (DoR).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Measured: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated disease control rate (DCR).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Measured: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated progression free survival (PFS).
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Measured: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated overall survival (OS) based on the RECIST v1.1 evaluation criteria for solid tumor treatment efficacy.
After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.
Measured: Approximately 12 months after the last patient enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start12 Mar 2026
- 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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT07380334
- Sponsor's protocol ID
- SHR-1049-101
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2026
- Last updated
- 16 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07380334
- Acronym / sponsor ID
- SHR-1049-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Feb 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 a multicenter, open label, dose exploration/efficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SHR-1049 Group - Queue 1 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
| SHR-1049 Group - Queue 2 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
| SHR-1049 Group - Queue 3 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
| SHR-1049 Group - Queue 4 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
| SHR-1049 Group - Queue 5 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
| SHR-1049 Group - Queue 6 | Experimental | Drug: SHR-1049 InjectionSpecified dose on specified days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;
- Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;
- Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;
- Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;
- Able to provide sufficient fresh or archived tumor tissue specimens for third-party central laboratories designated by the sponsor to test expression levels; For participants who are unable to provide tumor tissue samples, the decision to enroll will be made after joint evaluation by the researchers and the sponsor;
Key exclusion criteria (17 listed)
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;
- Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;
- Previous or concurrent presence of other malignant tumors;
- Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;
- Interstitial pneumonia/interstitial lung disease, non infectious pneumonia (such as radiation pneumonitis) that previously required steroid treatment; Currently present or suspected of having interstitial pneumonia/interstitial lung disease, non infectious pneumonia, or other active pneumonia; Severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other lung damage occurred within 6 months prior to the first use of medication; Individuals with active pulmonary tuberculosis;
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-1049 InjectionSHR-1049 injection. | Drug | SHR-1049 Group - Queue 1, SHR-1049 Group - Queue 2, SHR-1049 Group - Queue 3, SHR-1049 Group - Queue 4, SHR-1049 Group - Queue 5, SHR-1049 Group - Queue 6 |
Primary outcome
The incidence and severity of dose-limiting toxicity (DLT).
Time frame: Expected results within one year.
The first dosing cycle after each subject's enrollment is the DLT observation period.
Adverse events (AEs).
Time frame: Approximately 12 months after the last patient enrolled.
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Serious adverse events (SAEs).
Time frame: Approximately 12 months after the last patient enrolled.
Continuous observation from each participant's knowledge until the end of the safety follow-up period.
Maximum tolerated dose (MTD).
Time frame: Plan to obtain results within 10 months of the first dose ramp up.
Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.
Recommended dose for phase II clinical study (RP2D).
Time frame: Plan to obtain results within 20 months of the first dose ramp up.
Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.
7 secondary outcomes
Pharmacokinetics (PK) indicator - Blood drug concentration.
Time frame: The plan is to complete all evaluations within 2 years.
Immunogenic indicator - Anti-drug antibody (ADA) levels.
Time frame: The plan is to complete all evaluations within 2 years.
Effectiveness indicator - Researchers evaluated objective response rate (ORR).
Time frame: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated duration of response (DoR).
Time frame: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated disease control rate (DCR).
Time frame: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated progression free survival (PFS).
Time frame: Approximately 12 months after the last patient enrolled.
Effectiveness indicator - Researchers evaluated overall survival (OS) based on the RECIST v1.1 evaluation criteria for solid tumor treatment efficacy.
Time frame: Approximately 12 months after the last patient enrolled.
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 16 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1049 Injection in people with Advanced 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 10 inclusion and 17 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 16 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 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 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 Peng Xiu (+86-0518-82342973, peng.xiu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of dose-limiting toxicity (DLT). (time frame: Expected results within one year.). 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 16 Apr 2026.