CLDN18.2-positive Advanced Solid TumorPhase 1NCT06350006
SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
A Phase 1 study testing SHR-A1904; Adebrelimab and SHR-A1904; CAPOX; Adebrelimab in people with CLDN18.2-positive Advanced Solid Tumor, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CLDN18.2-positive Advanced Solid Tumor
- What is being tested?
- SHR-A1904; Adebrelimab and SHR-A1904; CAPOX; Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2024to 30 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
- Age 18 to 75 years old (including boundary values);
- Volunteer to participate in this clinical study and sign informed consent;
- ECOG score 0-1;
- Expected survival ≥3 months;
- Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
- positive CLDN18.2 expression in tumor tissue;
- There is at least one measurable lesion that meets the RECIST 1.1 criteria;
- Adequate bone marrow and organ function.
Who cannot join
- Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
- HER2 expression in tumor tissue is positive.
- The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
- Has ≥ grade 2 peripheral sensory neuropathy.
- Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
- Has a history or current history of meningeal metastasis; or active brain metastases.
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- Presence of dysphagia or other factors affecting the use of oral medications.
- Additional malignancy within the five years prior to the first administration or randomization.
- Has an active autoimmune disease or a history of autoimmune disease.
- Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.
- Has a history of clinically significant lung disease.
- Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
- There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.
- A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
- People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Has severe cardiovascular and cerebrovascular diseases.
- Gastrointestinal perforation and/or gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.
- In the investigator's judgment, the subject has other factors that could have affected the study results or led to the forced termination of the 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu
About this study
Official title: A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
This study consists of two research phases:
Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.
Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
- Conditions
- CLDN18.2-positive Advanced Solid Tumor
- Being tested
- SHR-A1904; Adebrelimab, SHR-A1904; CAPOX; Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1904; AdebrelimabDrug
SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab
SHR-A1904; CAPOX; AdebrelimabDrug
SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1904 combined with Adebrelimab | Experimental | SHR-A1904+ Adebrelimab Receives: Drug: SHR-A1904; Adebrelimab |
| SHR-A1904 combined with CAPOX and Adebrelimab | Experimental | SHR-A1904+ CAPOX+ Adebrelimab Receives: Drug: SHR-A1904; CAPOX; Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AE
Phase 1b
Measured: Up to follow-up period, approximately 24 months
Dose Limiting Toxicity (DLT)
Phase 1b
Measured: approximately 24 months
Maximal Tolerable Dose (MTD)
Phase 1b
Measured: approximately 24 months
Phase III Recommended Dose (RP3D)
Phase 1b
Measured: approximately 24 months
Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
Phase 3
Measured: approximately 36 months
Secondary outcomes (6)
SHR-A1904 toxin binding antibody
Phase 1b
Measured: approximately 24 months
SHR-A1904 Total antibody
Phase 1b
Measured: approximately 24 months
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Phase 1b
Measured: approximately 24 months
Expression level of CLDN18.2 in tumor tissues
Phase 1b
Measured: approximately 24 months
Overall survival (OS)
Phase 3
Measured: approximately 36 months
Incidence and severity of AE
Phase 3
Measured: approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start29 May 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLDN18.2-positive Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two stages, IB-A for dose escalation and IB-B for efficacy expansion. The Phase III multi-center, randomized ,active-controlled, Open-label study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients.
- Masking
- None (open label)
- Enrolment
- 924 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
- NCT06350006
- Sponsor's protocol ID
- SHR-A1904-301
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2024
- Last updated
- 31 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT06350006
- Acronym / sponsor ID
- SHR-A1904-301
- Conditions
- CLDN18.2-positive Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 5 Apr 2024 (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 consists of two research phases:
Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.
Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two stages, IB-A for dose escalation and IB-B for efficacy expansion. The Phase III multi-center, randomized ,active-controlled, Open-label study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients.
| Arm | Type | Receives |
|---|---|---|
| SHR-A1904 combined with Adebrelimab | Experimental | Drug: SHR-A1904; AdebrelimabSHR-A1904+ Adebrelimab |
| SHR-A1904 combined with CAPOX and Adebrelimab | Experimental | Drug: SHR-A1904; CAPOX; AdebrelimabSHR-A1904+ CAPOX+ Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years old (including boundary values);
- Volunteer to participate in this clinical study and sign informed consent;
- ECOG score 0-1;
- Expected survival ≥3 months;
- Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
Key exclusion criteria (18 listed)
- Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
- HER2 expression in tumor tissue is positive.
- The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
- Has ≥ grade 2 peripheral sensory neuropathy.
- Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
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-A1904; AdebrelimabSHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab | Drug | SHR-A1904 combined with Adebrelimab |
| SHR-A1904; CAPOX; AdebrelimabSHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin) | Drug | SHR-A1904 combined with CAPOX and Adebrelimab |
Primary outcome
Incidence and severity of AE
Time frame: Up to follow-up period, approximately 24 months
Phase 1b
Dose Limiting Toxicity (DLT)
Time frame: approximately 24 months
Phase 1b
Maximal Tolerable Dose (MTD)
Time frame: approximately 24 months
Phase 1b
Phase III Recommended Dose (RP3D)
Time frame: approximately 24 months
Phase 1b
Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria
Time frame: approximately 36 months
Phase 3
6 secondary outcomes
SHR-A1904 toxin binding antibody
Time frame: approximately 24 months
SHR-A1904 Total antibody
Time frame: approximately 24 months
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Time frame: approximately 24 months
Expression level of CLDN18.2 in tumor tissues
Time frame: approximately 24 months
Overall survival (OS)
Time frame: approximately 36 months
Incidence and severity of AE
Time frame: approximately 36 months
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 31 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 study testing SHR-A1904; Adebrelimab and SHR-A1904; CAPOX; Adebrelimab in people with CLDN18.2-positive Advanced 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 8 inclusion and 18 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 31 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 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 Qi Shi (0518-82342973, qi.shi.qs16@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AE (time frame: Up to follow-up period, approximately 24 months). 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 31 Dec 2025.