Salivary Gland TumorsPhase 2NCT05601401
Phase II Study of RC48-ADC in Treating Patients With Salivary Gland Tumors Expressing HER2
A Phase 2 study testing RC48-ADC in people with Salivary Gland Tumors, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Tumors
- What is being tested?
- RC48-ADC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2022to 31 Dec 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in the research and sign the informed consent form;
- Male or female, age ≥ 18;
- Expected survival time ≥ 12 weeks;
- Locally advanced or metastatic salivary gland malignant tumor confirmed by histopathology that cannot be completely resected by surgery;
- Subjects who have not received systemic anti-tumor treatment after being diagnosed as locally advanced or metastatic salivary gland malignant tumor that cannot be removed surgically; Or disease progression occurs after receiving at least first-line systematic treatment in the past, in which the patient has disease progression within 12 months after receiving neoadjuvant or adjuvant chemotherapy, and can be included in this clinical study;
- Have measurable lesions specified in RECIST v1.1 standard;
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- Subjects can provide the primary or metastatic tumor samples for HER2 detection; HER2 IHC is 2+or 3+;
- ECOG physical condition score 0-2;
- Adequate heart, bone marrow, liver and kidney functions (subject to the normal value of the research center):
- ① Left ventricular ejection fraction ≥ 50%;
- ② Hemoglobin ≥ 9g/dL;
- ③ Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
- ④ Platelet ≥ 100 × 109/L；
- ⑤ In patients without liver metastasis, serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); Total serum bilirubin in patients with liver metastasis ≤ 3 × ULN；
- ⑥ ALT and AST ≤ 2.5 in the absence of liver metastasis × ULN, ALT and AST ≤ 5 in case of liver metastasis × ULN；
- ⑦ Blood creatinine ≤ 1.5 × ULN；
- For female subjects: they should be surgical sterilized or postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as intrauterine device [IUD], contraceptives or condoms) during the study treatment period and within 6 months after the end of the study treatment period. The serum or urine pregnancy test must be negative within 7 days before the study enrollment, and they must be non lactating. Male subjects should agree to use at least one medically approved contraceptive measure (such as condom, abstinence, etc.) during the study treatment period and within 6 months after the end of the study treatment period;
- Willing and able to follow the trial and follow-up procedures.
Who cannot join
- Known allergic to recombinant humanized anti HER2 monoclonal antibody MMAE coupling agent drugs and their related components;
- Have received anti-tumor treatment (including chemotherapy, radiotherapy, immunotherapy, etc.) or participated in other clinical research treatments within 3 weeks before the start of the study treatment, or the toxicity related to the previous anti-tumor treatment has not recovered to grade 0-1 (except grade 2 alopecia);
- He has been treated with recombinant humanized anti HER2 monoclonal antibody MMAE coupling agent in the past;
- Major surgery was carried out within 4 weeks before the start of the study drug administration and it was not completely recovered;
- Other serious and uncontrollable concomitant diseases that may affect the protocol compliance or interfere with the interpretation of results, including active infection or progressive (serious) infection, uncontrollable diabetes Cardio cerebral vascular disease (Grade III or IV heart failure defined by New York Heart Association, more than Grade II heart block, acute myocardial infarction, unstable arrhythmia or unstable angina pectoris in the past 6 months, cerebral infarction in the past 6 months, except lacunar cerebral infarction) or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism;
- Patients with other malignant tumors within 3 years before the start of the study drug administration, but excluding obviously cured malignant tumors or curable cancers, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ; Remarks: Limited low-risk prostate cancer (defined as patients with stage ≤ T2a, Gleason score ≤ 6 and PSA<10ng/mL (if measured) at the time of diagnosis of prostate cancer who have received radical treatment and have no biochemical recurrence of prostate specific antigen (PSA) can participate in this study);
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- Have central nervous system (CNS) metastasis and/or cancerous meningitis. Subjects who have received brain metastasis treatment can consider participating in this study, provided that the condition is stable for at least 3 months, no disease progression is confirmed by imaging examination within 4 weeks before the first administration of the study, and all neurological symptoms have recovered to the baseline level, there is no evidence that new or expanded brain metastasis has occurred, and radiation, surgery or steroid treatment is stopped at least 28 days before the first administration of the study treatment. This exception does not include malignant meningitis, regardless of its clinical stability should be excluded;
- Pregnant or lactating women;
- HIV test result is positive;
- Patients with active hepatitis B or hepatitis C
- ① HBsAg positive persons also detected positive copy number of HBV DNA; HBV DNA must be detected when such patients are studied and screened;
- ② Patients with positive HCV antibody test results can only be included in this study if the PCR test result of HCV RNA is negative.
- There are active or progressive infections requiring systematic treatment, such as active pulmonary tuberculosis;
- Suffering from any other disease, metabolic abnormality, physical examination abnormality or laboratory examination abnormality, according to the judgment of the investigator, it is reasonable to suspect that the patient has a certain disease or state that is not suitable for the use of the study drug, or will affect the interpretation of the study results, or put the patient at high risk;
- It is estimated that the patient's compliance to participate in this clinical study is insufficient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Ningning Li, Doctor
About this study
Official title: Phase II Clinical Study to Assess the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody MMAE Coupling Agent in Treating Patients With Locally Advanced or Metastatic Salivary Gland Tumors Expressing HER2
The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer.
Read the detailed description
The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer. Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
- Conditions
- Salivary Gland Tumors
- Being tested
- RC48-ADC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48-ADCDrug
Also called RC48
RC48-ADC 2.0 mg/kg IV every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients receive RC48-ADC. Receives: Drug: RC48-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Tumor response was assessed by investigator according to RECIST v1.1.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Secondary outcomes (3)
Objective Response Rate （ORR）
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Measured: From date of randomization until the date of death from any cause. Assessed up to 60 months.
Disease Control Rate （DCR）
CR+PR+SD
Measured: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start31 Mar 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland TumorsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601401
- Sponsor's protocol ID
- RCVDORIIR002
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study to Assess the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody MMAE Coupling Agent in Treating Patients With Locally Advanced or Metastatic Salivary Gland Tumors Expressing HER2
- ClinicalTrials.gov ID
- NCT05601401
- Acronym / sponsor ID
- RCVDORIIR002
- Conditions
- Salivary Gland Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Nov 2022 (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.
The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer.
Detailed description
The goal of this clinical trial is to learn about the efficacy and safety of RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic salivary cancer. Participants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: RC48-ADCPatients receive RC48-ADC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Voluntary consent to participate in the research and sign the informed consent form;
- Male or female, age ≥ 18;
- Expected survival time ≥ 12 weeks;
- Locally advanced or metastatic salivary gland malignant tumor confirmed by histopathology that cannot be completely resected by surgery;
- Subjects who have not received systemic anti-tumor treatment after being diagnosed as locally advanced or metastatic salivary gland malignant tumor that cannot be removed surgically; Or disease progression occurs after receiving at least first-line systematic treatment in the past, in which the patient has disease progression within 12 months after receiving neoadjuvant or adjuvant chemotherapy, and can be included in this clinical study;
Key exclusion criteria (15 listed)
- Known allergic to recombinant humanized anti HER2 monoclonal antibody MMAE coupling agent drugs and their related components;
- Have received anti-tumor treatment (including chemotherapy, radiotherapy, immunotherapy, etc.) or participated in other clinical research treatments within 3 weeks before the start of the study treatment, or the toxicity related to the previous anti-tumor treatment has not recovered to grade 0-1 (except grade 2 alopecia);
- He has been treated with recombinant humanized anti HER2 monoclonal antibody MMAE coupling agent in the past;
- Major surgery was carried out within 4 weeks before the start of the study drug administration and it was not completely recovered;
- Other serious and uncontrollable concomitant diseases that may affect the protocol compliance or interfere with the interpretation of results, including active infection or progressive (serious) infection, uncontrollable diabetes Cardio cerebral vascular disease (Grade III or IV heart failure defined by New York Heart Association, more than Grade II heart block, acute myocardial infarction, unstable arrhythmia or unstable angina pectoris in the past 6 months, cerebral infarction in the past 6 months, except lacunar cerebral infarction) or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism;
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-ADCAlso: RC48RC48-ADC 2.0 mg/kg IV every 14 days | Drug | Study arm |
Primary outcome
Progression-free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Tumor response was assessed by investigator according to RECIST v1.1.
3 secondary outcomes
Objective Response Rate （ORR）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause. Assessed up to 60 months.
Disease Control Rate （DCR）
Time frame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 60 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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. This study is not recruiting at the moment.
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 RC48-ADC in people with Salivary Gland Tumors, run by Peking Union Medical College 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 18 inclusion and 15 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 1 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ningning Li, Doctor (+86-01069158750, rain.cmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.). 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 1 Nov 2022.