Gastric CancerPhase 2/3NCT05980481
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
A Phase 2/3 study testing RC48-ADC（2.5mg/kg）, Trastuzumab and Toripalimab in people with Gastric Cancer, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- RC48-ADC（2.5mg/kg）, Trastuzumab and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 10 Oct 2026
- Phase
- Phase 2/3
- 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
- Voluntary agreement to provide written informed consent.
- Age:18-75 years（including 18 and 75）.
- Predicted survival ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function.
- All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma.
- Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence >6 months from completion of therapy are permitted;
- HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+ or IHC0.
Who cannot join
- Active central nervous system (CNS) metastases.
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.
- Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- RC48-ADC（2.5mg/kg）, Trastuzumab, Toripalimab, Oxaliplatin（130mg/m2 ）, Capecitabine（1000mg/m2）
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48-ADC（2.5mg/kg）Drug
Also called Disitamab Vedotin
2.5 mg/kg intravenous infusion every 2 weeks
TrastuzumabDrug
Also called Trastuzumab Injection
First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks
ToripalimabDrug
Also called JS001
3.0 mg/kg intravenous infusion every 2 weeks
Oxaliplatin（130mg/m2 ）Drug
Also called Oxaliplatin injection
130mg/m2 intravenous infusion Q3W
Capecitabine（1000mg/m2）Drug
Also called Capecitabine Tablets
1000mg/m2 per os Q3W
RC48-ADC（2.0mg/kg）Drug
Also called Disitamab Vedotin
2.0 mg/kg intravenous infusion every 2 weeks
Capecitabine（750mg/m2）Drug
Also called Capecitabine Tablets
750mg/m2 per os Q3W
Oxaliplatin（100mg/m2 ）Drug
Also called Oxaliplatin injection（100mg/m2 ）
100mg/m2 intravenous infusion Q3W
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC+Toripalimab+CAPOX (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: RC48-ADC（2.5mg/kg）; Drug: Toripalimab; Drug: Oxaliplatin（130mg/m2 ）; Drug: Capecitabine（1000mg/m2） |
| RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and Trastuzumab every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: RC48-ADC（2.5mg/kg）; Drug: Trastuzumab; Drug: Toripalimab |
| RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression) | Experimental | Participants with HER2-intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: RC48-ADC（2.5mg/kg）; Drug: Toripalimab; Drug: Oxaliplatin（130mg/m2 ）; Drug: Capecitabine（1000mg/m2）; Drug: RC48-ADC（2.0mg/kg）; Drug: Capecitabine（750mg/m2）; Drug: Oxaliplatin（100mg/m2 ） |
| Toripalimab+Trastuzumab+CAPOX (HER2-high expression) | Active comparator | Participants with HER2-high expression (IHC2+FISH+ or IHC3+) will receive of Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: Trastuzumab; Drug: Toripalimab; Drug: Oxaliplatin（130mg/m2 ）; Drug: Capecitabine（1000mg/m2） |
| Toripalimab+CAPOX (HER2- intermediate/low expression) | Active comparator | Participants with HER2- intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: Toripalimab; Drug: Oxaliplatin（130mg/m2 ）; Drug: Capecitabine（1000mg/m2） |
| RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression) | Experimental | Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and Capecitabine every 3 weeks (Q3W), as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: RC48-ADC（2.5mg/kg）; Drug: Trastuzumab; Drug: Toripalimab; Drug: Capecitabine（1000mg/m2） |
| RC48-ADC+Toripalimab+CAPOX (HER2-negative) | Experimental | Participants with HER2-negative (IHC0) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: RC48-ADC（2.5mg/kg）; Drug: Toripalimab; Drug: RC48-ADC（2.0mg/kg）; Drug: Capecitabine（750mg/m2）; Drug: Oxaliplatin（100mg/m2 ） |
| Toripalimab+CAPOX (HER2- negative) | Active comparator | Participants with HER2- negative (IHC 0) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). Receives: Drug: Toripalimab; Drug: Oxaliplatin（130mg/m2 ）; Drug: Capecitabine（1000mg/m2） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).
Measured: Up to approximately 2 years
Secondary outcomes (5)
Safety(adverse event)
to evaluate safety including adverse event rate and adverse event grade.
Measured: Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Measured: Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Measured: Up to approximately 2 years
Disease Control Rate(DCR)
DCR is the proportion of subjects with optimal overall response to achieve objective remission or stable disease over the course of the study
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start4 Aug 2023
- Primary completion10 Jul 2025
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by RemeGen 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Na Su, PhD, Study director, RemeGen Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980481
- Sponsor's protocol ID
- RC48-C027
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Trastuzumab as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression or Non-expression
- ClinicalTrials.gov ID
- NCT05980481
- Acronym / sponsor ID
- RC48-C027
- Conditions
- Gastric Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 8 Aug 2023 (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 is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC+Toripalimab+CAPOX (HER2-high expression) | Experimental | Drug: RC48-ADC（2.5mg/kg）, Drug: Toripalimab, Drug: Oxaliplatin（130mg/m2 ）, Drug: Capecitabine（1000mg/m2）Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression) | Experimental | Drug: RC48-ADC（2.5mg/kg）, Drug: Trastuzumab, Drug: ToripalimabParticipants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and Trastuzumab every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression) | Experimental | Drug: RC48-ADC（2.5mg/kg）, Drug: Toripalimab, Drug: Oxaliplatin（130mg/m2 ）, Drug: Capecitabine（1000mg/m2）, Drug: RC48-ADC（2.0mg/kg）, Drug: Capecitabine（750mg/m2）, Drug: Oxaliplatin（100mg/m2 ）Participants with HER2-intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| Toripalimab+Trastuzumab+CAPOX (HER2-high expression) | Active comparator | Drug: Trastuzumab, Drug: Toripalimab, Drug: Oxaliplatin（130mg/m2 ）, Drug: Capecitabine（1000mg/m2）Participants with HER2-high expression (IHC2+FISH+ or IHC3+) will receive of Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| Toripalimab+CAPOX (HER2- intermediate/low expression) | Active comparator | Drug: Toripalimab, Drug: Oxaliplatin（130mg/m2 ）, Drug: Capecitabine（1000mg/m2）Participants with HER2- intermediate/low expression (IHC 2+/FISH- or IHC 1+) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression) | Experimental | Drug: RC48-ADC（2.5mg/kg）, Drug: Trastuzumab, Drug: Toripalimab, Drug: Capecitabine（1000mg/m2）Participants with HER2-high expression(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) , Trastuzumab every 3 weeks (Q3W) and Capecitabine every 3 weeks (Q3W), as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| RC48-ADC+Toripalimab+CAPOX (HER2-negative) | Experimental | Drug: RC48-ADC（2.5mg/kg）, Drug: Toripalimab, Drug: RC48-ADC（2.0mg/kg）, Drug: Capecitabine（750mg/m2）, Drug: Oxaliplatin（100mg/m2 ）Participants with HER2-negative (IHC0) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
| Toripalimab+CAPOX (HER2- negative) | Active comparator | Drug: Toripalimab, Drug: Oxaliplatin（130mg/m2 ）, Drug: Capecitabine（1000mg/m2）Participants with HER2- negative (IHC 0) will receive of Toripalimab every 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary agreement to provide written informed consent.
- Age:18-75 years（including 18 and 75）.
- Predicted survival ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function.
Key exclusion criteria (5 listed)
- Active central nervous system (CNS) metastases.
- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal.
- Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
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 |
|---|---|---|
| RC48-ADC（2.5mg/kg）Also: Disitamab Vedotin2.5 mg/kg intravenous infusion every 2 weeks | Drug | RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), RC48-ADC+Toripalimab+CAPOX (HER2-negative), RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression) |
| TrastuzumabAlso: Trastuzumab InjectionFirst load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks | Drug | RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression), RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression), Toripalimab+Trastuzumab+CAPOX (HER2-high expression) |
| ToripalimabAlso: JS0013.0 mg/kg intravenous infusion every 2 weeks | Drug | RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), RC48-ADC+Toripalimab+CAPOX (HER2-negative), RC48-ADC+Toripalimab+Trastuzumab (HER2-high expression), Toripalimab+CAPOX (HER2- intermediate/low expression), Toripalimab+CAPOX (HER2- negative), Toripalimab+Trastuzumab+CAPOX (HER2-high expression) |
| Oxaliplatin（130mg/m2 ）Also: Oxaliplatin injection130mg/m2 intravenous infusion Q3W | Drug | RC48-ADC+Toripalimab+CAPOX (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), Toripalimab+CAPOX (HER2- intermediate/low expression), Toripalimab+CAPOX (HER2- negative), Toripalimab+Trastuzumab+CAPOX (HER2-high expression) |
| Capecitabine（1000mg/m2）Also: Capecitabine Tablets1000mg/m2 per os Q3W | Drug | RC48-ADC + Toripalimab + Trastuzumab + Capecitabine (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-high expression), RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), Toripalimab+CAPOX (HER2- intermediate/low expression), Toripalimab+CAPOX (HER2- negative), Toripalimab+Trastuzumab+CAPOX (HER2-high expression) |
| RC48-ADC（2.0mg/kg）Also: Disitamab Vedotin2.0 mg/kg intravenous infusion every 2 weeks | Drug | RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), RC48-ADC+Toripalimab+CAPOX (HER2-negative) |
| Capecitabine（750mg/m2）Also: Capecitabine Tablets750mg/m2 per os Q3W | Drug | RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), RC48-ADC+Toripalimab+CAPOX (HER2-negative) |
| Oxaliplatin（100mg/m2 ）Also: Oxaliplatin injection（100mg/m2 ）100mg/m2 intravenous infusion Q3W | Drug | RC48-ADC+Toripalimab+CAPOX (HER2-intermediate/low expression), RC48-ADC+Toripalimab+CAPOX (HER2-negative) |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 2 years
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).
5 secondary outcomes
Safety(adverse event)
Time frame: Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Disease Control Rate(DCR)
Time frame: Up to approximately 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 29 Sep 2025.
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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. This study is not recruiting at the moment.
Na Su, PhD study director
RemeGen Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RC48-ADC（2.5mg/kg）, Trastuzumab and Toripalimab in people with Gastric Cancer, run by RemeGen 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 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 2 years). 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 Sep 2025.