GCPhase 2NCT07817654
Trastuzumab Combined With Retlirafusp Alfa in Treating HER2（Human Epidermal Growth Factor Receptor 2） 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
A Phase 2 study testing Trastuzumab Rezetecan+Retlirafusp alfa in people with GC and GEJC, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Using a prospective, exploratory trial design, we aim to evaluate the efficacy and safety of RC-Trastuzumab combined with Rilafup Alpha in treating first-line systemically treated HER2（Human Epidermal Growth Factor Receptor 2 ） medium-to-high expressing gastric/gastroesophageal junction adenocarcinoma that has failed… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Trastuzumab Rezetecan+Retlirafusp alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation with follow-up;
- Age ≥18 years;
- Eastern Cooperative Oncology Group（ECOG） score 0-1;
- Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
- Immunohistochemistry (IHC) testing for Her2 expression: IHC3+ or IHC2+;
- First-line standard treatment failure in gastric adenocarcinoma or gastroesophageal junction adenocarcinoma: (1) postoperative recurrence or metastasis patients progressing during concurrent chemoradiotherapy; (2) for neoadjuvant/adjuvant therapy containing immunotherapy, if patients progress during treatment or within 6 months after treatment, it is also considered first-line treatment failure;
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- Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
- Major organ functions are normal, meeting the following criteria:(1) Blood routine test standards must meet (no blood transfusion or blood products, and no use of G-CSF or other hematopoietic stimulating factors within 14 days to correct): A. Hemoglobin (Hb) ≥90 g/L; B. Absolute neutrophil count (ANC) ≥1.5 ×10^9/L; C. Platelet count (PLT) ≥80×10^9/L; (2) Biochemical tests must meet the following standards: A. Total bilirubin (TBIL) <1.5 × upper limit of normal (ULN);B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 ULN, or <5 ULN for patients with liver metastasis; C. Serum creatinine (Cr) ≤1.5 ULN or estimated creatinine clearance >60 ml/min (Cockcroft-Gault formula); D. Urinalysis results: urine protein (UPRO) <2 or 24-hour urine protein <1 g; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); (4) Coagulation: international normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN;(5) Pulmonary function: forced expiratory volume in 1 second (FEV1) ≥1.2 L, FEV1% ≥70%, carbon monoxide diffusing capacity (DLCO) ≥50%; (6) Cardiac chocardiography: left ventricular ejection fraction (LVEF) ≥50%;(7) Electrocardiogram Fridericia-corrected QT interval (QTcF): women <470 ms, men <450 ms; (8) Others: lipase ≤1.5×ULN (if lipase >1.5×ULN without clinical or imaging evidence of pancreatitis, enrollment is allowed); amylase ≤1.5×ULN (if amylase >1.5×ULN without clinical or imaging evidence of pancreatitis, enrollment is allowed); alkaline phosphatase (ALP) ≤2.5×ULN.
- Women of childbearing potential must agree to use effective contraception during the study and for 6 months after the study; must have a negative serum or urine pregnancy test within 7 days before enrollment, and must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study.
Who cannot join
- Known allergy to any investigational drug or its excipients, or allergy to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.).
- (1) Received any investigational drug within 4 weeks before the first use of the study drug; (2) subjects who require systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressants within 2 weeks before the first use of the study drug, except for using corticosteroids for local esophageal inflammation, allergy prevention, or nausea and vomiting; (3) other special situations need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or local steroids and adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are allowed; (4) subjects who have received anti-cancer vaccines or live vaccines within 4 weeks before the first administration of the study drug.
- Having any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), except for vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood; autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone and type 1 diabetes patients using a stable dose of insulin can be included.
- History of immunodeficiency, including positive HIV test, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant or allogeneic bone marrow transplantation.
- Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring medical intervention.
- Severe infection (CTCAE > Grade 2) within 4 weeks before first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infections with complications; baseline chest imaging indicating active lung inflammation; symptoms or signs of infection within 2 weeks before first use of the study drug requiring oral or intravenous antibiotics, except for prophylactic antibiotic use; history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung diseases; active pulmonary tuberculosis found by history or CT, or a history of active pulmonary tuberculosis within 1 year before enrollment, or a history of active pulmonary tuberculosis over 1 year ago but not properly treated; subjects with active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL) or hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay).
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- Before using the study drug for the first time, diagnosed with any other malignant tumor is excluded, except for those with low risk of metastasis and death (5-year survival rate >90%), such as fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
- Pregnant or breastfeeding women; subjects of reproductive potential who are unwilling or unable to use effective contraception.
- Patients who, in the investigator's judgment, are considered not suitable to enroll.
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
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Ying Liu Chief Physician, +86 13783604602, zlyyliuying1664@zzu.edu.cn
About this study
Official title: Prospective, Exploratory Clinical Study of Trastuzumab Combined With Retlirafusp Alfa in Treating HER2 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
Using a prospective, exploratory trial design, we aim to evaluate the efficacy and safety of RC-Trastuzumab combined with Rilafup Alpha in treating first-line systemically treated HER2（Human Epidermal Growth Factor Receptor 2 ） medium-to-high expressing gastric/gastroesophageal junction adenocarcinoma that has failed standard therapy. Participants, after being fully informed and signing the consent form, and passing the screening, enter the treatment phase. The trial medications include RC-Trastuzumab and Rilafup Alpha: RC-Trastuzumab: 4.8 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal. Rilafup Alpha: 1800 mg or 30 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal, with a maximum treatment duration of 2 years.
Efficacy assessment: Imaging is done every 2 cycles from the start of therapy until the end of treatment, consent withdrawal, or death. If participants leave the study for any reason and no imaging has been done within 4 weeks before stopping treatment, imaging should be performed at exit. Participants with CR or PR are to have a repeat imaging evaluation 4 weeks later for confirmation. According to RECIST(Response Evaluation Criteria in Solid Tumors version ) 1.1 criteria, for those showing initial PD but clinically stable, confirmation should be done after a 4-week interval, and imaging resumes at the next scheduled time point.
Additionally, the study evaluates drug safety and survival. Safety assessment: Adverse events are graded according to NCI-CTCAE(National Cancer Institute Common Terminology Criteria for Adverse Events) 6.0. During the trial, adverse events should be recorded accurately, including onset, severity, relation to study drugs, duration, actions taken, and outcome. Survival assessment: The follow-up period starts after the last dose of study drug. The study center conducts follow-ups every 3 months during the first year after treatment, then every 6 months, until death or study completion. Follow-ups by phone are acceptable.
- Being tested
- Trastuzumab Rezetecan+Retlirafusp alfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan+Retlirafusp alfaDrug
Trastuzumab Rezetecan: 4.8 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study. Retlirafusp alfa: 1800 mg or 30 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study, with a maximum treatment duration of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab+Retlirafusp alfa | Experimental | Not described Receives: Drug: Trastuzumab Rezetecan+Retlirafusp alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From the first day of medication to the end of every two cycles.(every two cycles is 42 days)
Secondary outcomes (5)
disease control rate
Measured: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Progression-free survival
Measured: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Duration of relief
Measured: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Overall survival
Measured: :It is the time from the start of treatment under the study protocol until death from any cause.
AE incidence
Measured: From the first day of medication to the end of every cycle. (every cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GCStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817654
- Sponsor's protocol ID
- Breakthrough 01
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Exploratory Clinical Study of Trastuzumab Combined With Retlirafusp Alfa in Treating HER2 2+/3+ Gastric/Gastroesophageal Junction Adenocarcinoma After First-line Systemic Therapy Failure
- ClinicalTrials.gov ID
- NCT07817654
- Acronym / sponsor ID
- Breakthrough 01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Sep 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.
Using a prospective, exploratory trial design, we aim to evaluate the efficacy and safety of RC-Trastuzumab combined with Rilafup Alpha in treating first-line systemically treated HER2（Human Epidermal Growth Factor Receptor 2 ） medium-to-high expressing gastric/gastroesophageal junction adenocarcinoma that has failed standard therapy. Participants, after being fully informed and signing the consent form, and passing the screening, enter the treatment phase. The trial medications include RC-Trastuzumab and Rilafup Alpha: RC-Trastuzumab: 4.8 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal. Rilafup Alpha: 1800 mg or 30 mg/kg i.v.gtt on day 1, every 3 weeks; continue until disease progression, intolerance, or study withdrawal, with a maximum treatment duration of 2 years.
Efficacy assessment: Imaging is done every 2 cycles from the start of therapy until the end of treatment, consent withdrawal, or death. If participants leave the study for any reason and no imaging has been done within 4 weeks before stopping treatment, imaging should be performed at exit. Participants with CR or PR are to have a repeat imaging evaluation 4 weeks later for confirmation. According to RECIST(Response Evaluation Criteria in Solid Tumors version ) 1.1 criteria, for those showing initial PD but clinically stable, confirmation should be done after a 4-week interval, and imaging resumes at the next scheduled time point.
Additionally, the study evaluates drug safety and survival. Safety assessment: Adverse events are graded according to NCI-CTCAE(National Cancer Institute Common Terminology Criteria for Adverse Events) 6.0. During the trial, adverse events should be recorded accurately, including onset, severity, relation to study drugs, duration, actions taken, and outcome. Survival assessment: The follow-up period starts after the last dose of study drug. The study center conducts follow-ups every 3 months during the first year after treatment, then every 6 months, until death or study completion. Follow-ups by phone are acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab+Retlirafusp alfa | Experimental | Drug: Trastuzumab Rezetecan+Retlirafusp alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation with follow-up;
- Age ≥18 years;
- Eastern Cooperative Oncology Group（ECOG） score 0-1;
- Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
- Immunohistochemistry (IHC) testing for Her2 expression: IHC3+ or IHC2+;
Key exclusion criteria (9 listed)
- Known allergy to any investigational drug or its excipients, or allergy to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.).
- (1) Received any investigational drug within 4 weeks before the first use of the study drug; (2) subjects who require systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressants within 2 weeks before the first use of the study drug, except for using corticosteroids for local esophageal inflammation, allergy prevention, or nausea and vomiting; (3) other special situations need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or local steroids and adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are allowed; (4) subjects who have received anti-cancer vaccines or live vaccines within 4 weeks before the first administration of the study drug.
- Having any active autoimmune disease or a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), except for vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood; autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone and type 1 diabetes patients using a stable dose of insulin can be included.
- History of immunodeficiency, including positive HIV test, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplant or allogeneic bone marrow transplantation.
- Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring medical intervention.
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 |
|---|---|---|
| Trastuzumab Rezetecan+Retlirafusp alfaTrastuzumab Rezetecan: 4.8 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study. Retlirafusp alfa: 1800 mg or 30 mg/kg i.v.gtt. on day 1, every 3 weeks; use until disease progression, intolerance, or withdrawal from the study, with a maximum treatment duration of 2 years. | Drug | Trastuzumab+Retlirafusp alfa |
Primary outcome
Objective response rate
Time frame: From the first day of medication to the end of every two cycles.(every two cycles is 42 days)
5 secondary outcomes
disease control rate
Time frame: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Progression-free survival
Time frame: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Duration of relief
Time frame: From the first day of medication to the end of every two cycles. (every two cycles is 42 days).
Overall survival
Time frame: :It is the time from the start of treatment under the study protocol until death from any cause.
AE incidence
Time frame: From the first day of medication to the end of every cycle. (every cycle is 21 days).
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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 Trastuzumab Rezetecan+Retlirafusp alfa in people with GC and GEJC, run by Henan Cancer Hospital 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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 Sep 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 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 Ying Liu (+8613783604602, zlyyliuying1664@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From the first day of medication to the end of every two cycles.(every two cycles is 42 days)). 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 14 Sep 2026.