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Trial Title:
Phase II Study of RC48-ADC in Treating Patients With Salivary Gland Tumors Expressing HER2
NCT ID:
NCT05601401
Condition:
Salivary Gland Tumors
Conditions: Official terms:
Salivary Gland Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48-ADC
Description:
RC48-ADC 2.0 mg/kg IV every 14 days
Arm group label:
Study arm
Other name:
RC48
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary consent to participate in the research and sign the informed consent form;
2. Male or female, age ≥ 18;
3. Expected survival time ≥ 12 weeks;
4. Locally advanced or metastatic salivary gland malignant tumor confirmed by
histopathology that cannot be completely resected by surgery;
5. 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;
6. Have measurable lesions specified in RECIST v1.1 standard;
7. Subjects can provide the primary or metastatic tumor samples for HER2 detection;
HER2 IHC is 2+or 3+;
8. ECOG physical condition score 0-2;
9. 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;
10. 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;
11. Willing and able to follow the trial and follow-up procedures.
Exclusion Criteria:
1. Known allergic to recombinant humanized anti HER2 monoclonal antibody MMAE coupling
agent drugs and their related components;
2. 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);
3. He has been treated with recombinant humanized anti HER2 monoclonal antibody MMAE
coupling agent in the past;
4. Major surgery was carried out within 4 weeks before the start of the study drug
administration and it was not completely recovered;
5. 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;
6. 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);
7. 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;
8. Pregnant or lactating women;
9. HIV test result is positive;
10. 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.
11. There are active or progressive infections requiring systematic treatment, such as
active pulmonary tuberculosis;
12. 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;
13. It is estimated that the patient's compliance to participate in this clinical study
is insufficient.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ningning Li, Doctor
Start date:
March 31, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05601401