Advanced Solid TumorsPhase 2NCT06895928
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
A Phase 2 study testing SHR-A2102, Bevacizumab Injection and Adebelimab Injection in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-A2102, Bevacizumab Injection and Adebelimab Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to Dec 2028
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of signing the informed consent is 18 -70 years, regardless of gender.
- At least one measurable lesion according to RECIST v1.1 criteria.
- The ECOG score is 0 or 1.
- Expected survival ≥12 weeks.
- Good level of organ function.
- Have the ability to give informed consent and to comply with the treatment plan.
- Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
Who cannot join
- Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy.
- Subjects with uncontrolled tumor-related pain.
- Received antitumor therapy within 4 weeks before the start of the study.
- Subjects with severe cardiovascular and cerebrovascular disease.
- History of immunodeficiency, including a positive HIV test.
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
Shanxi Cancer hospital
Taiyuan, Shanxi, 030001
Jie Wang, +86-0351-4881611, zlhuxi@163.com
Jie Wang
About this study
Official title: A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-A2102, Bevacizumab Injection, Adebelimab Injection, Ametinib Mesylate Tablets, Osimertinib Mesylate Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102Drug
SHR-A2102 for injection.
Bevacizumab InjectionDrug
Bevacizumab injection.
Adebelimab InjectionDrug
Adebelimab injection.
Ametinib Mesylate TabletsDrug
Ametinib mesylate tablets.
Osimertinib Mesylate TabletsDrug
Osimertinib mesylate tablets.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Drug: SHR-A2102; Drug: Bevacizumab Injection; Drug: Adebelimab Injection; Drug: Ametinib Mesylate Tablets; Drug: Osimertinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From day 1 to 90 days after the last dose.
Serious adverse events (SAEs)
Measured: From day 1 to 90 days after the last dose.
Objective response rate (ORR)
Measured: About 2 years.
Secondary outcomes (4)
Disease control rate (DCR)
Measured: About 2 years.
Duration of response (DOR)
Measured: About 2 years.
Progression free survival (PFS)
Measured: About 2 years.
Overall survival (OS)
Measured: About 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start28 Mar 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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT06895928
- Sponsor's protocol ID
- SHR-A2102-209
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 22 Apr 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06895928
- Acronym / sponsor ID
- SHR-A2102-209
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Mar 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 efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced 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 |
|---|---|---|
| Treatment Group | Experimental | Drug: SHR-A2102, Drug: Bevacizumab Injection, Drug: Adebelimab Injection, Drug: Ametinib Mesylate Tablets, Drug: Osimertinib Mesylate Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The age of signing the informed consent is 18 -70 years, regardless of gender.
- At least one measurable lesion according to RECIST v1.1 criteria.
- The ECOG score is 0 or 1.
- Expected survival ≥12 weeks.
- Good level of organ function.
Key exclusion criteria (6 listed)
- Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy.
- Subjects with uncontrolled tumor-related pain.
- Received antitumor therapy within 4 weeks before the start of the study.
- Subjects with severe cardiovascular and cerebrovascular disease.
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-A2102SHR-A2102 for injection. | Drug | Treatment Group |
| Bevacizumab InjectionBevacizumab injection. | Drug | Treatment Group |
| Adebelimab InjectionAdebelimab injection. | Drug | Treatment Group |
| Ametinib Mesylate TabletsAmetinib mesylate tablets. | Drug | Treatment Group |
| Osimertinib Mesylate TabletsOsimertinib mesylate tablets. | Drug | Treatment Group |
Primary outcome
Adverse events (AEs)
Time frame: From day 1 to 90 days after the last dose.
Serious adverse events (SAEs)
Time frame: From day 1 to 90 days after the last dose.
Objective response rate (ORR)
Time frame: About 2 years.
4 secondary outcomes
Disease control rate (DCR)
Time frame: About 2 years.
Duration of response (DOR)
Time frame: About 2 years.
Progression free survival (PFS)
Time frame: About 2 years.
Overall survival (OS)
Time frame: About 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 22 Apr 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 2 study testing SHR-A2102, Bevacizumab Injection and Adebelimab Injection in people with Advanced Solid Tumors, 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 7 inclusion and 6 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 22 Apr 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 phase mean?
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 Yang Wu (+86-0518-82342973, yang.wu.yw96@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From day 1 to 90 days after the last dose.). The study lists 3 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 22 Apr 2025.