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Gastric CancerPhase 1NCT06078982

Posterior-line Treatment With Disitamab Vedotin Plus PD-1 in Advanced HER2-low Expressing Gastric Cancer

A Phase 1 study testing Disitamab Vedotin and Toripalimab in people with Gastric Cancer and HER2-low-expressing Gastric Cancer, run by Shanghai East Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, prospective, non-randomized, multi-center/single-center, open-label, phase I clinical study aimed at evaluating the efficacy and safety of Disitamab Vedotin in combination with PD-1 as posterior line treatment for patients with advanced HER2-low expressing gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Disitamab Vedotin and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
6 Jun 2023to Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must voluntarily join this study and sign an informed consent form;
  • Age 18-70 years old (including 18 years old and 70 years old);
  • Expected survival period ≥ 12 weeks;
  • ECOG physical fitness score 0 or 1 point;
  • Patients with incurable and unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) confirmed by histology or cytology;
  • The HER2 immunohistochemistry (IHC) test results are IHC 1+, the subject's previous test results (confirmed by the investigator) or the test results of the research center are acceptable;
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  • The patient has received second-line treatment (at least) after tumor recurrence/metastasis
  • Evidence of tumor disease progression during or after the most recent treatment, as documented by medical history or confirmed by the investigator;
  • At least one measurable lesion according to RECIST 1.1;
  • For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptives) during the study treatment period and within 6 months after the end of the study treatment period. pills or condoms), must have a negative blood pregnancy test within 7 days prior to study enrollment, and must be non-lactating; for male subjects: should for surgical sterilization, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period of the experimental group subjects;
  • Sufficient organ function:
  • Bone marrow function: hemoglobin ≥ 9g/dL; absolute neutrophil count ≥ 1.5×109/L; platelet ≥ 100×109/L;
  • Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤ 2.5×ULN, and in the presence of liver metastases ALT, AST, and ALP are ≤ 5×ULN;
  • Renal function (subject to the normal value of the clinical trial center): blood creatinine ≤ 1.5×ULN, or creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method, or 24-hour urine CrCl ≥ 60 mL/min;
  • Heart function: New York Heart Association (NYHA) classification < Grade 3; left ventricular ejection fraction ≥ 50%;
  • Able to understand trial requirements, willing and able to comply with trial and follow-up procedures.

Who cannot join

  • Brain metastasis or leptomeningeal metastasis;
  • Tumor lesions with a bleeding tendency (e.g., 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, risk of gastrointestinal hemorrhage in the judgment of the investigator) or previous blood transfusions in the 4 weeks prior to study drug administration;
  • Suffering from other malignant tumors within 5 years before signing the informed consent form (non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated, except for malignant tumors that are considered cured);
  • Received chemotherapy, radiotherapy, and immune therapy within 4 weeks before the start of the study drug
  • Received palliative radiotherapy for bone metastases within 2 weeks before the start of the study drug;
  • Received anti-tumor traditional Chinese medicine treatment within 2 weeks before the start of the study drug;
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  • The toxicity caused by previous anti-tumor therapy has not recovered to CTCAE (version 4.03) grade 0-1 (except for alopecia, hyperpigmentation, and long-term toxicity caused by radiotherapy, which in the judgment of the investigator cannot be recovered);
  • Prior treatment with T-DM1 or participation in a clinical study of this type of drug;
  • The study drug has been used within 4 weeks before the start of the study drug;
  • Major surgery has been performed within 4 weeks before the start of the study drug and the patient has not fully recovered;
  • Have been vaccinated with live vaccines within 4 weeks before the start of the study drug or plan to receive any vaccines during the study period;
  • Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, and myocardial infarction, occurred within 1 year before the study drug;
  • Suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver cirrhosis, angina pectoris, serious arrhythmia, etc.;
  • Suffering from active infection requiring systemic treatment;
  • History of active tuberculosis;
  • Positive human immunodeficiency virus (HIV) test result;
  • Patients with active hepatitis B or C (HBsAg positive and HBV DNA titers higher than the upper limit of normal when HBsAg is positive; HCVAb positive and HCV RNA titers higher than the upper limit of normal when HBsAg is positive);
  • Presence of third interstitial fluid that cannot be controlled by drainage or other methods (including massive pleural effusion or ascites);
  • Known to have hypersensitivity or delayed allergic reactions to certain components of RC48-ADC or similar drugs;
  • Exclude, at the investigator's discretion, other conditions that might confuse the study results or affect the subjects' ability to follow the study procedures, such as alcoholism, drug abuse, mental disorders, criminal detention, etc.;
  • Suffering from any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory test, according to the judgment of the investigator, there is reason to suspect that the subject has a certain disease or condition that is not suitable for the use of the study drug, or will affect the research results interpretations, or situations that place the subject at high risk;
  • Women who are pregnant or breastfeeding or women/men who are planning to give birth;
  • It is estimated that the subjects' compliance to participate in this clinical study is insufficient or the investigators believe that there are other factors that are not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

Jin Li, MD,PhD contact

+86-13761222111

lijin@csco.org.cn

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai

    Jin Li, MD,PhD, +86-13761222111, lijin@csco.org.cn

    Jin Li, MD,PhD

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Disitamab Vedotin Combined With PD-1 in Posterior Line Therapy of Advanced HER2-low Expressing Gastric Cancer

This is a single-arm, prospective, non-randomized, multi-center/single-center, open-label, phase I clinical study aimed at evaluating the efficacy and safety of Disitamab Vedotin in combination with PD-1 as posterior line treatment for patients with advanced HER2-low expressing gastric cancer.

Being tested
Disitamab Vedotin, Toripalimab
Keywords
HER2-low-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 VedotinDrug

    Also called RC48

    2.0mg/kg, intravenously D1, once every 14 days (Q2W)

  • ToripalimabDrug

    3.0 mg/kg, once every 14 days (Q2W)

Study groups in NCT06078982
Study groupRoleWhat they receive
Combination of Disitamab Vedotin and ToripalimabExperimentalParticipants will receive Disitamab Vedotin + Toripalimab every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: Disitamab Vedotin; Drug: Toripalimab

What is being measured

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

  1. Objective response rate (ORR)

    The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST version 1.1

    Measured: up to 2 years

Secondary outcomes (4)

  1. 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

  2. Overall survival (OS)

    OS is defined as the time from the starting date of study drug to the date of death due to any cause.

    Measured: 12 months after the last subject participating in

  3. 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

  4. Drug-related safety indicators

    Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events（n, %）

    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.

  1. First posted12 Oct 2023
  2. Study start6 Jun 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078982
Sponsor's protocol ID
RCVDGIIIR011
Status last verified
Oct 2023
First submitted
11 Aug 2023
Last updated
12 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Disitamab Vedotin and Toripalimab in people with Gastric Cancer and HER2-low-expressing Gastric Cancer, run by Shanghai East 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 16 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jin Li, MD,PhD (+86-13761222111, lijin@csco.org.cn), 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: up to 2 years). 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 NCT06078982.

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 12 Oct 2023.

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