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Gastric CancerPhase 2/3NCT06221748

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

A Phase 2/3 study testing Disitamab Vedotin Injection, Cadonilimab Injection and Paclitaxel Injection in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by RemeGen Co., Ltd. at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Disitamab Vedotin Injection, Cadonilimab Injection and Paclitaxel Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
12 sitesChina
Study dates
22 Feb 2024to Dec 2027
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

  • Voluntarily agreed to participate in the study and signed an informed consent form;
  • Age 18-75 years(both 18 and 75);
  • Expected survival ≥ 12 weeks
  • ECOG physical condition score of 0 or 1
  • Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology
  • Subjects will only have failed or been intolerant to prior standard first-line therapy (excluding paclitaxel), with no restriction on prior treatment with a PD-1/PD-L1 inhibitor.
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  • Confirmation of HER2 (IHC 1+, 2+, or 3+) and PD-L1 expression: for Phase II enrolled subjects, results of investigator-confirmed HER2 and PD-L1 expression will be accepted; for Phase III enrolled subjects, HER2 and PD-L1 expression will be accepted only as results from the central laboratory.
  • Bone marrow function:
  • Hemoglobin ≥ 9 g/dL (no blood transfusion and no erythropoietin treatment within 2 weeks prior to the examination);
  • Absolute neutrophil count ≥ 1.5 × 109/L (must not receive granulocyte colony-stimulating factor treatment within 2 weeks prior to the examination)
  • Platelet count ≥ 90 × 109/L (no platelet transfusion or treatment with recombinant human thrombopoietin within 2 weeks before the test);
  • Liver function (based on normal values at the Clinical Trials Center):
  • Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and Mentholatum aminotransferase (AST) ≤ 2.5 × ULN in the absence of hepatic metastases; ALT and AST ≤ 5 × ULN in the presence of hepatic metastases;
  • Renal function (based on normal values at the Clinical Trials Center):
  • Blood creatinine ≤ 1.5 x ULN, or creatinine clearance (CrCl) ≥ 60 mL/min calculated by the Cockcroft-Gault formula method, or measured 24-hour urine CrCl ≥ 60 mL/min;
  • Coagulation:
  • Prothrombin time (PT) ≤ 1.5 x ULN;
  • Thrombin time (TT) ≤ 1.5 × ULN;
  • Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
  • Cardiac function:
  • New York Heart Association (NYHA) classification <3;
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • The subject is able to provide specimens for central laboratory testing/review (at least 5 tissue sections) from the site of the primary or metastatic focus of the tumor within 3 years, preferably specimens taken after failure of first-line therapy;
  • Have at least one measurable lesion according to RECISTv1.1 criteria;
  • For female subjects: should be surgically sterilized, post-menopausal, or agree to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) for the duration of the study treatment and for 6 months after the end of the study treatment period; must have had a negative blood pregnancy test within 7 days prior to the study drug administration and must not be breastfeeding; and must not donate eggs for a period of 6 months from the time of signing of the informed consent form to the time of the last administration of the study drug. No egg donation for 6 months. For male subjects: should be surgically sterilized or agree to use a medically approved method of contraception during and for 6 months after the end of study treatment; no sperm donation from the time of signing the informed consent until at least 4 months after the last dose of study drug;
  • Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow-up procedures.

Who cannot join

  • Metastatic CNS and/or meningeal carcinomatosis；
  • prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection; prior treatment with cardinolizumab
  • Prior anti-cancer therapy resulting in toxicity that has not recovered to CTCAE (version 5.0) ≤ Grade 1 (except for hair loss, hyperpigmentation, or other conditions that do not increase the risk of the subject's use of the drug determined by the investigators;
  • Radical radiotherapy within 3 months prior to study dosing; palliative radiotherapy 2 weeks prior to dosing is permitted, at a dose that meets local diagnostic criteria for palliative care and with radiotherapy coverage of less than 30% of the bone marrow area;
  • Prior major surgery within 4 weeks before study dose start and incomplete recovery
  • Received a live vaccine within 28 days prior to the start of the first study dose or plan to receive any vaccine during the study period
Show all 23Show fewer
  • Third interstitial effusion associated with clinical symptoms or that requires symptomatic treatment;
  • Ongoing grade ≥2 sensorimotor or motoneuropathy;
  • serum virology (based on site normal values):
  • Positive Hepatitis B virus surface antigen (HBsAg) test result with a positive HBV DNA copy number;
  • Positive test result for Hepatitis C Antibody (HCVAb) (enrollment in the study is only possible if the PCR test result for HCV RNA is negative);
  • Positive test result for human immunodeficiency virus antibody (HIVAb).；
  • Serious arterial/venous or cardiovascular accidents, such as deep vein thrombosis ( except asymptomatic interstitial vein thrombosis which does not require special treatment), pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, angina pectoris, etc., except for lacunar cerebral infarction, which is asymptomatic and does not require clinical intervention, have occurred in the last 6 months prior to the study drug administration;
  • Tumor lesions with bleeding tendency (e.g., presence of active ulcerated tumor lesions with a positive fecal occult blood test, history of vomiting blood or black stools within 2 months prior to signing the informed consent form, risk of gastrointestinal hemorrhage in the judgment of the investigator, etc.), or receipt of blood transfusion 4 weeks prior to study drug administration;;
  • The occurrence of an active or progressive infection requiring systemic treatment (trial drug may be initiated 2 weeks after completion of anti-infective therapy);
  • The presence of unsteady controlled systemic disease as judged by the investigator, including diabetes and hypertension, hepatocirrhosis, interstitial pneumonitis, and obstructive lung disease.
  • The existence of active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory agents, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study dosing, allowing for related replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency);
  • Other malignancy within 5 years prior to the start of study dosing, with the exception of the following: malignancies that are expected to resolve with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);
  • prior history of allogeneic hematopoietic stem cell transplantation or organ transplantation;
  • known hypersensitivity to immunosuppressants and any other antibody-drug conjugate and their components and any of the drugs in this study;
  • women who are pregnant or breast-feeding;
  • Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition that is unsuitable for the use of the study medication, would interfere with the interpretation of the results of the study, or puts the subject at a high risk of developing a condition;
  • subjects whose participation in this study is estimated to be insufficiently adherent or who, in the judgment of the investigator, have other factors that make them unsuitable for participation in this study.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jianmin Fang, Ph.D contact

+8610-58075763

Jianminfang@hotmail.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, M.D.

    Lin Shen, M.D

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Zhenyang Liu, M.D

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Hongfeng Gou, M.D

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Yanqiao Zhang, M.D

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Changzheng Li, M.D

    Changzheng Li

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Lin Xie, M.D

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

    Jing Lv, M.D

    Not yet recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Jun Zhang, M.D

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Huiting Xu, M.D

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Feng Ye, M.D

    Not yet recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Yuan Yuan, M.D

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Yanru Qin, M.D

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Read the detailed description

This is an open-label, randomized, multicenter, Phase II/III Study designed to evaluate safety and efficacy of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

This clinical study was divided into two parts, phase II and III.Part I: Phase II study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus Disitamab Vedotin versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Part II: Phase III study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (±7 days) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).

All patients who discontinue treatment will be followed for survival every 3 months until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).

Being tested
Disitamab Vedotin Injection, Cadonilimab Injection, Paclitaxel Injection
Keywords
Gastric cancer, Gastroesophageal junction adenocarcinoma, HER2- expressing
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disitamab Vedotin InjectionDrug

    Also called DV,RC48

    Phase II and III study ：2.5mg/kg, intravenous infusion，D1, every 2 weeks

  • Cadonilimab InjectionDrug

    Also called AK104, Cadonilimab Injection

    Phase II and III study ：6.0mg/kg, intravenous infusion，D1, every 2 weeks.

  • Paclitaxel InjectionDrug

    Phase II and III study ：Calculate dosage based on body surface are,160mg/m2,intravenous infusion，D1,D8 every 3 weeks

Study groups in NCT06221748
Study groupRoleWhat they receive
Disitamab Vedotin + CadonilimabExperimentalDisitamab Vedotin With Cadonilimab
Receives: Drug: Disitamab Vedotin Injection; Drug: Cadonilimab Injection
Disitamab VedotinExperimentalDisitamab Vedotin arm
Receives: Drug: Disitamab Vedotin Injection
PaclitaxelExperimentalPaclitaxel Arm
Receives: Drug: Paclitaxel Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective remission rate (ORR) (Phase II)

    ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)

    Measured: Up to approximately 2 years

  2. Percentage of Participants With Adverse Events (AEs)(Phase II)

    Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0

    Measured: Up to approximately 2 years

  3. Progression-Free Survival(PFS) （IRC）（ Phase III)

    PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)

    Measured: Up to approximately 2 years

  4. Overall Survival (OS)(Phase III)

    OS was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Up to approximately 2 years

Secondary outcomes (9)

  1. Progression-Free Survival(PFS)（investigator）(Phase II and Phase III)

    PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)

    Measured: Up to approximately 2 years

  2. Overall Survival (OS)(Phase II)

    OS was defined as the time from the date of randomization to the date of death from any cause.

    Measured: Up to approximately 2 years

  3. Objective remission rate (ORR) （investigator） (Phase III)

    ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)

    Measured: Up to approximately 2 years

  4. Disease Control Rate (DCR) (Phase II and Phase III)

    Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.

    Measured: Until progression, assessed up to approximately 2 years

  5. Duration of response (DoR) (Phase II and Phase III)

    Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1

    Measured: Until progression, assessed up to approximately 2 years

  6. Type, incidence, relatedness, severity, and seriousness of AEs

    According to NCI-CTCAE Version 5.0 per each treatment arm

    Measured: Up to approximately 2 years

  7. Incidence of laboratory tests abnormalities

    To be summarized using descriptive statistics

    Measured: Up to follow-up period, approximately 2 years

  8. Incidence of ECG abnormalities

    To be summarized using descriptive statistics

    Measured: Up to follow-up period, approximately 2 years

  9. Incidence of echocardiograms abnormalities

    Change from baseline of LVEF

    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.

  1. First posted24 Jan 2024
  2. Study start22 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221748
Sponsor's protocol ID
RC48-C035
Status last verified
Jan 2024
First submitted
15 Jan 2024
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Disitamab Vedotin Injection, Cadonilimab Injection and Paclitaxel Injection in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by RemeGen Co., Ltd. at 12 sites 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 27 inclusion and 23 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

Contact Jianmin Fang, Ph.D (+8610-58075763, Jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission rate (ORR) (Phase II) (time frame: Up to approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06221748.

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 3 Apr 2024.

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