Gynecological MalignancyPhase 2NCT04965519
A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies
A Phase 2 study testing RC48-ADC in people with Gynecological Malignancy, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the effectiveness and safety of intravenous injection of RC48-ADC in the treatment of HER2 expression (HER2 positive and HER2 low expression) gynecological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Malignancy
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2021to Jun 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Meet all the conditions of any of the following queues:
- Queue one:
- Histologically confirmed patients with recurrent or metastatic cervical cancer who have failed at least the first-line platinum-containing standard treatment or failed concurrent radiotherapy and chemotherapy;
- Not suitable for surgery or radiotherapy.
- Queue two:
- Ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer confirmed histologically;
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- The subject has previously received a standard platinum-containing chemotherapy regimen, and at the same time meets any of the following criteria:
- Platinum-resistant relapsed patients who have undergone at least 2 lines (can contain BRCA mutations or HRD-positive patients who have failed PARP inhibitors) standard treatment failure (relapse or progression time and previous platinum-containing regimen last chemotherapy (at least 4 cycles) The interval between time is less than 6 months); or at least three lines (patients who have failed PARP inhibitors on BRCA mutations or HRD-positive patients) platinum-sensitive relapsed patients who have failed standard treatment (the time to relapse or progression is related to The interval between the last platinum-containing chemotherapy (at least 4 cycles) is ≥ 6 months); Note: The definition of recurrence or progression (meet any of the following conditions): a) There is clearly recorded imaging progress; b) CA-125 continues to rise (CA-125 ≥ 2 times the upper limit of normal, and it needs to be confirmed after 1 week ) With clinical symptoms or physical examination suggesting disease progression;
- Queue three:
- Recurrent or metastatic endometrial cancer confirmed histologically;
- Patients who have failed the standard treatment of at least first-line platinum-containing chemotherapy;
- Not suitable for surgery or radiotherapy.
- Queue four:
- Recurrent or metastatic other gynecological malignancies (vulvar cancer, vaginal cancer, primary sarcoma of the gynecological reproductive system, etc.) that have failed standard treatments confirmed by histology;
- Not suitable for surgery or radiotherapy.
- 2.Voluntarily agree to participate in the research and sign an informed consent form;
- 3. Female, age ≥18 years old;
- 4. Expected survival period ≥ 12 weeks;
- 5.The central laboratory confirms the expression of HER2: IHC 1+, 2+ or 3+; the subject can provide specimens of the primary or metastatic tumor site for HER2 detection (paraffin blocks, paraffin-embedded sections or fresh tissue sections are acceptable); IHC2+ Of subjects need to be tested for FISH. Note: The scoring standard for HER2 testing is determined by the central laboratory.
- 6. With measurable lesions specified by RECIST 1.1 standard;
- 7. ECOG physical status 0 or 1 point;
- 8. Sufficient organ functions should meet the following criteria during the screening period (the normal value is subject to the clinical trial center): Left ventricular ejection fraction ≥50%; Hemoglobin ≥9g/dL; Absolute neutrophil count (ANC)≥1.5×109/L; Platelets ≥100 ×109/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5 × ULN when there is no liver metastasis, and ALT and AST≤5 × ULN when there is liver metastasis; Serum creatinine≤1.5×ULN or calculate creatinine clearance rate (CrCl)≥50 mL/min according to Cockcroft-Gault formula method;
- 9 .Female subjects should be surgically sterilized, post-menopausal patients, or agree to use at least one medically approved contraceptive method (such as intrauterine contraceptive devices, contraceptives, or condom).The blood pregnancy test must be negative within 7 days before study entry, and it must be a non-lactating period.
- 10. Willing and able to follow the trial and follow-up procedures.
Who cannot join
- 1.Suffering from central nervous system metastasis and/or cancerous meningitis. Subjects who have received brain metastasis therapy may consider participating in this study, provided that the condition is stable for at least 3 months, no disease progression has been confirmed by imaging examination within 4 weeks before the first dose of the study, and all neurological symptoms have recovered At baseline, there is no evidence of new or enlarged brain metastases, and radiation, surgery, or steroid therapy should be discontinued at least 28 days before the first dose of study treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether the clinical condition is stable or not;
- 2. The toxicity caused by previous anti-tumor treatments has not been restored to CTCAE (version 5.0) 0-1 grade (except for 2nd degree alopecia);
- 3. Major surgery has been performed within 4 weeks before the start of study administration and has not fully recovered;
- 4. A large amount of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment;
- 5.Serum virology examination (subject to the normal value of the research center): The HBsAg test result is positive, and the HBV DNA copy number is positive at the same time; HCVAb test result is positive (only if the PCR test result of HCV RNA is negative, it can be selected for this study); HIVAb test result is positive.
- 6. Have received live vaccines within 4 weeks before the start of the study administration or plan to receive any vaccines during the study period (except the new crown vaccination);
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- 7. Heart failure classified by the New York College of Cardiology (NYHA) as grade 3 and above;
- 8. Severe arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents occurred within 1 year before the study administration, such as deep vein thrombosis (not including asymptomatic intermuscular vein thrombosis without special treatment), pulmonary embolism, cerebral infarction, Cerebral hemorrhage, myocardial infarction, etc., except for lacunar infarction that is asymptomatic and does not require clinical intervention;
- 9. There are active or advanced infections that require systemic treatment, such as active tuberculosis;
- 10.There are systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.;
- 11. There are active autoimmune diseases requiring systemic treatment (such as immunomodulatory drugs, corticosteroids or immunosuppressive agents) within 2 years before the start of study administration, and related alternative treatments (such as thyroxine, insulin, or renal or Physiological corticosteroid replacement therapy for pituitary insufficiency);
- 12. Suffered from other malignant tumors within 5 years before the start of study administration, except for the following conditions: Malignant tumors that can be expected to heal after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ treated by radical surgery);
- 13. Have previously received allogeneic hematopoietic stem cell transplantation;
- 14. Have received other antibody-conjugated drug therapy in the past;
- 15. Those who are known to be allergic to recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent drugs and their components;
- 16. Suffer from any other diseases, metabolic abnormalities, abnormal physical examinations or abnormal laboratory examinations. According to the judgment of the investigator, there is reason to suspect that the patient has a certain disease or condition that is not suitable for the use of the study drug, or will affect the interpretation of the study results , Or put the patient in a high-risk situation;
- 17. It is estimated that the compliance of patients to participate in this clinical study is insufficient.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, 100021
Lingying Wu, 010-67781331, wulingying@csco.org.cn
About this study
Official title: An Open, Multi-cohort, Multi-center Phase II Basket Clinical Study of RC48-ADC Monotherapy in the Treatment of HER2-expressing (HER2-positive and HER2 Low Expression) Gynecological Malignancies
This study will evaluate the effectiveness and safety of intravenous injection of RC48-ADC in the treatment of HER2 expression (HER2 positive and HER2 low expression) gynecological malignancies.
Read the detailed description
This study is an open, multi-cohort, multi-center Phase II basket clinical study that included HER2 expression (HER2 positive and HER2 low expression) gynecological malignant tumor subjects. The four cohorts include cervical cancer, ovarian epithelial cancer、 fallopian tube cancer and primary peritoneal cancer, endometrial cancer and other gynecological malignancies (vulvar cancer, vaginal cancer, primary sarcoma of the gynecological reproductive system, etc.). Each cohort enrolled 30 subjects. Among them, IHC+, IHC2+, IHC3+ subjects were enrolled at least 5 subjects, and the remaining 15 subjects were not restricted by HER2 expression. HER2 expression includes HER2 positive and HER2 low expression. HER2 positive is defined by the immunohistochemical IHC 2+/fluorescence in situ hybridization technique FISH+ or IHC 3+ judged by the central laboratory. HER2 low expression is defined as IHC 2+/FISH- or IHC+ as determined by the central laboratory. The Molecular Pathology Department of the Department of Pathology, Cancer Hospital of the Chinese Academy of Medical Sciences will serve as the research center laboratory to confirm the HER2 status (including IHC and FISH tests).
- Conditions
- Gynecological Malignancy
- 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 Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
2.0mg/kg IV every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| RC48-ADC | Experimental | Eligible subjects received RC48-ADC treatment after enrollment, at a dose of 2.0 mg/kg, once every 2 weeks (the dosing time window in all cycles is -1 to 2 days), and the administration method is intravenous Drip. Receives: Drug: RC48-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) as assessed by the Independent Review Committee
Objective Response Rate is defined as the percentage of participants with a complete response (CR) or partial response (PR)
Measured: 2 years
Secondary outcomes (5)
Objective Response Rate（ORR）as assessed by investigator
Objective Response Rate is defined as the percentage of participants with a complete response (CR) or partial response (PR)
Measured: 2 years
Duration of Response（DOR）
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Measured: 2 years
Disease control rate（DCR）
DCR is defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
Measured: 2 years
Progression Free Survival（PFS）
PFS is defined as the time from the first administration of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first
Measured: 2 years
Overall survival （OS）
OS is defined as the time from the first administration of study treatment to death from any cause.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start21 Dec 2021
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological MalignancyStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingying Wu, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965519
- Sponsor's protocol ID
- RC48-C018
- Status last verified
- Dec 2023
- First submitted
- 7 Jul 2021
- Last updated
- 18 Dec 2023
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-cohort, Multi-center Phase II Basket Clinical Study of RC48-ADC Monotherapy in the Treatment of HER2-expressing (HER2-positive and HER2 Low Expression) Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT04965519
- Acronym / sponsor ID
- RC48-C018
- Conditions
- Gynecological Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Jul 2021 (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.
This study will evaluate the effectiveness and safety of intravenous injection of RC48-ADC in the treatment of HER2 expression (HER2 positive and HER2 low expression) gynecological malignancies.
Detailed description
This study is an open, multi-cohort, multi-center Phase II basket clinical study that included HER2 expression (HER2 positive and HER2 low expression) gynecological malignant tumor subjects. The four cohorts include cervical cancer, ovarian epithelial cancer、 fallopian tube cancer and primary peritoneal cancer, endometrial cancer and other gynecological malignancies (vulvar cancer, vaginal cancer, primary sarcoma of the gynecological reproductive system, etc.). Each cohort enrolled 30 subjects. Among them, IHC+, IHC2+, IHC3+ subjects were enrolled at least 5 subjects, and the remaining 15 subjects were not restricted by HER2 expression. HER2 expression includes HER2 positive and HER2 low expression. HER2 positive is defined by the immunohistochemical IHC 2+/fluorescence in situ hybridization technique FISH+ or IHC 3+ judged by the central laboratory. HER2 low expression is defined as IHC 2+/FISH- or IHC+ as determined by the central laboratory. The Molecular Pathology Department of the Department of Pathology, Cancer Hospital of the Chinese Academy of Medical Sciences will serve as the research center laboratory to confirm the HER2 status (including IHC and FISH tests).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48-ADC | Experimental | Drug: RC48-ADCEligible subjects received RC48-ADC treatment after enrollment, at a dose of 2.0 mg/kg, once every 2 weeks (the dosing time window in all cycles is -1 to 2 days), and the administration method is intravenous Drip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 1. Meet all the conditions of any of the following queues:
- Queue one:
- Queue two:
- Platinum-resistant relapsed patients who have undergone at least 2 lines (can contain BRCA mutations or HRD-positive patients who have failed PARP inhibitors) standard treatment failure (relapse or progression time and previous platinum-containing regimen last chemotherapy (at least 4 cycles) The interval between time is less than 6 months); or at least three lines (patients who have failed PARP inhibitors on BRCA mutations or HRD-positive patients) platinum-sensitive relapsed patients who have failed standard treatment (the time to relapse or progression is related to The interval between the last platinum-containing chemotherapy (at least 4 cycles) is ≥ 6 months); Note: The definition of recurrence or progression (meet any of the following conditions): a) There is clearly recorded imaging progress; b) CA-125 continues to rise (CA-125 ≥ 2 times the upper limit of normal, and it needs to be confirmed after 1 week ) With clinical symptoms or physical examination suggesting disease progression;
- Queue three:
Key exclusion criteria (17 listed)
- 1.Suffering from central nervous system metastasis and/or cancerous meningitis. Subjects who have received brain metastasis therapy may consider participating in this study, provided that the condition is stable for at least 3 months, no disease progression has been confirmed by imaging examination within 4 weeks before the first dose of the study, and all neurological symptoms have recovered At baseline, there is no evidence of new or enlarged brain metastases, and radiation, surgery, or steroid therapy should be discontinued at least 28 days before the first dose of study treatment. This exception does not include cancerous meningitis, which should be excluded regardless of whether the clinical condition is stable or not;
- 2. The toxicity caused by previous anti-tumor treatments has not been restored to CTCAE (version 5.0) 0-1 grade (except for 2nd degree alopecia);
- 3. Major surgery has been performed within 4 weeks before the start of study administration and has not fully recovered;
- 4. A large amount of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment;
- 5.Serum virology examination (subject to the normal value of the research center): The HBsAg test result is positive, and the HBV DNA copy number is positive at the same time; HCVAb test result is positive (only if the PCR test result of HCV RNA is negative, it can be selected for this study); HIVAb test result is positive.
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: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection2.0mg/kg IV every 2 weeks | Drug | RC48-ADC |
Primary outcome
Objective Response Rate (ORR) as assessed by the Independent Review Committee
Time frame: 2 years
Objective Response Rate is defined as the percentage of participants with a complete response (CR) or partial response (PR)
5 secondary outcomes
Objective Response Rate（ORR）as assessed by investigator
Time frame: 2 years
Duration of Response（DOR）
Time frame: 2 years
Disease control rate（DCR）
Time frame: 2 years
Progression Free Survival（PFS）
Time frame: 2 years
Overall survival （OS）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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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.
Lingying Wu principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Gynecological Malignancy, run by RemeGen Co., Ltd. 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 24 inclusion and 17 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 18 Dec 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 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 Lingying Wu, M.D. (010-67781331, wulingying@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) as assessed by the Independent Review Committee (time frame: 2 years). 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 18 Dec 2023.