HER2-positive Gastric CancerPhase 2NCT06492317
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer
A Phase 2 study testing Disitamab Vedotin and Cadonilimab in people with HER2-positive Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Gastric Cancer
- What is being tested?
- Disitamab Vedotin and Cadonilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2024to 6 Jul 2027
- 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
- Age: more than 18 years, gender is not limited;
- Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;
- Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);
- At least 1 measurable lesion as determined by RECIST 1.1;
- There is no prior systematic treatment, or the patient has received neoadjuvant/adjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;
- Eastern Cooperative Oncology Group (ECOG)performance status of 0-1;
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- Adequate organ function:
- Bone marrow function: Hemoglobin count (HGB)≥80g/L;
- Neutrophil count (NE)≥1.5×109/L;
- White blood cell count (WBC)≥3.5×109/L;
- Platelet count (PLT)≥100×109/L；
- Liver function: i. Serum total bilirubin (TBIL)≤1.5×ULN; ii. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)≤3×ULN, patients with liver metastasis≤5×ULN;
- Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL/min;
- Cardiac function: New York Heart Association (NYHA) classification<Grade 3; Left ventricular ejection fraction≥50%;
- At least 3 months life expectancy ;
- The female of childbearing age must have taken reliable contraceptive measures or conducted a negative pregnancy test (serum or urine) within 7 days before enrollment, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; the male must agree to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial;
- Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.
Who cannot join
- Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
- Uncontrollable cardiovascular and cerebrovascular events , such as:
- NYHA grade 2 or above heart failure;
- Unstable angina pectoris;
- Myocardial infarction occurred within 12 months;
- Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
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- Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
- Serious cardiovascular and cerebrovascular events occurred within 12 months; Uncontrolled hypertension, i.e. systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg after treatment;
- A history of arterial thrombosis or deep vein thrombosis within 6 months , or with evidence of bleeding tendency or medical history within 2 months, regardless of the severity;
- Stroke event or transient ischemic attack occurred within 12 months.
- Received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
- A history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
- A history of active immune deficiency or autoimmune diseases, including HIV positive, or others acquired or congenital immune deficiency diseases, or organ transplantation;
- Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. A history of active tuberculosis infection ≥ 1 year should also be excluded, unless proved has been completed appropriate treatment;
- Brain metastasis or leptomeningeal metastasis;
- Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the drugs;
- Another clinically detectable primary malignant tumor at the time of recruitment, or other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
- Any major surgery was performed ≤ 28 days before the drugs administration;
- History of allogeneic stem cell transplantation or organ transplantation;
- Be suffering gastrointestinal diseases: uodenal ulcer, ulcerative colitis, intestinal obstruction and others at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;
- Live vaccine are inoculated within 4 weeks (inclusive) before the first administration of the drugs, not including seasonal influenza vaccines but intranasal vaccine;
- Other factors may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;
- Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
- Others conditions do not meet the inclusion according to the judgment of the investigator.
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
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yanru Qin, Doctor, 0371-66271157, yanruqin@163.com
Yongxu Jia, Doctor, 0371-66271156, jiayongxu111@126.com
About this study
Official title: A Prospective, Single-center, Phase II Clinical Study of First-line Treatment for HER2 (Human Epidermal Growth Factor Receptor 2) Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma
Read the detailed description
This study is a prospective, single-arm, single-center phase II trial. The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check the adverse events (AEs) when participants are administered the combination treatment regimen. This study will include patients with HER2-overexpressing, locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer who have not previously received systemic treatment including chemotherapy, targeted therapy, and immunotherapy. Enrolled patients will be treated with disitamab vedotin (2.5mg/kg, D1, ivdrip, Q2W) combined with cadonilimab (6mg/kg, D1, ivdrip, Q2W) until progressive disease (PD) or intolerable toxicity.
- Conditions
- HER2-positive Gastric Cancer
- Being tested
- Disitamab Vedotin, Cadonilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Also called RC48
Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, Q2W (every 2 weeks)
CadonilimabDrug
Also called AK104
Cadonilimab: 6mg/kg, d1, ivdrip, Q2W (every 2 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Disitamab vedotin plus cadonilimab | Experimental | Disitamab vedotin: 2.5mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; Cadonilimab: 6mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; until progressive disease (PD) or intolerable toxicity Receives: Drug: Disitamab Vedotin; Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 6 months after the last subject participating in
Secondary outcomes (5)
duration of response (DOR)
DOR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 12 months after the last subject participating in
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects
Measured: 12 months after the last subject participating in
time to response (TTR)
TTR (per RECIST 1.1) is defined as the time from the starting date of study drug to the first time complete response (CR) or partial response (PR)
Measured: 12 months after the last subject participating in
progression-free survival (PFS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12 months after the last subject participating in
overall survival (OS)
Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Measured: 12 months after the last subject participating in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start6 Jul 2024 (estimated)
- Primary completion6 Jul 2026 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongxu Jia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492317
- Sponsor's protocol ID
- S2021-K006-001
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2024
- Last updated
- 9 Jul 2024
- 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Phase II Clinical Study of First-line Treatment for HER2 (Human Epidermal Growth Factor Receptor 2) Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab
- ClinicalTrials.gov ID
- NCT06492317
- Acronym / sponsor ID
- S2021-K006-001
- Conditions
- HER2-positive Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 6 Jul 2024 (estimated)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 9 Jul 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.
A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma
Detailed description
This study is a prospective, single-arm, single-center phase II trial. The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check the adverse events (AEs) when participants are administered the combination treatment regimen. This study will include patients with HER2-overexpressing, locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer who have not previously received systemic treatment including chemotherapy, targeted therapy, and immunotherapy. Enrolled patients will be treated with disitamab vedotin (2.5mg/kg, D1, ivdrip, Q2W) combined with cadonilimab (6mg/kg, D1, ivdrip, Q2W) until progressive disease (PD) or intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab vedotin plus cadonilimab | Experimental | Drug: Disitamab Vedotin, Drug: CadonilimabDisitamab vedotin: 2.5mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; Cadonilimab: 6mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; until progressive disease (PD) or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age: more than 18 years, gender is not limited;
- Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;
- Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);
- At least 1 measurable lesion as determined by RECIST 1.1;
- There is no prior systematic treatment, or the patient has received neoadjuvant/adjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;
Key exclusion criteria (24 listed)
- Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
- Uncontrollable cardiovascular and cerebrovascular events , such as:
- Received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
- A history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
- A history of active immune deficiency or autoimmune diseases, including HIV positive, or others acquired or congenital immune deficiency diseases, or organ transplantation;
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 |
|---|---|---|
| Disitamab VedotinAlso: RC48Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, Q2W (every 2 weeks) | Drug | Disitamab vedotin plus cadonilimab |
| CadonilimabAlso: AK104Cadonilimab: 6mg/kg, d1, ivdrip, Q2W (every 2 weeks) | Drug | Disitamab vedotin plus cadonilimab |
Primary outcome
objective response rate (ORR)
Time frame: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
5 secondary outcomes
duration of response (DOR)
Time frame: 12 months after the last subject participating in
disease control rate (DCR)
Time frame: 12 months after the last subject participating in
time to response (TTR)
Time frame: 12 months after the last subject participating in
progression-free survival (PFS)
Time frame: 12 months after the last subject participating in
overall survival (OS)
Time frame: 12 months after the last subject participating in
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 9 Jul 2024.
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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 Disitamab Vedotin and Cadonilimab in people with HER2-positive Gastric Cancer, run by The First Affiliated Hospital of Zhengzhou University 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 17 inclusion and 24 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 9 Jul 2024. 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 Yanru Qin, Doctor (0371-66271157, yanruqin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 6 months after the last subject participating in). 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 9 Jul 2024.