A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies

NCT04965519 | Unknown Phase 2

• 1 other identifier: RC48-C018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecological Malignancy

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (5)

• Objective Response Rate（ORR）as assessed by investigator

  2 years

• Duration of Response（DOR）

  2 years

• Disease control rate（DCR）

  2 years

• Progression Free Survival（PFS）

  2 years

• Overall survival （OS）

  2 years

Study Arms (1)

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.

Drug: RC48-ADC

Interventions

RC48-ADC DRUG

2.0mg/kg IV every 2 weeks

Also known as: Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection

RC48-ADC

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• 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.

You may not qualify if:

• 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;
• \. 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);
• \. Major surgery has been performed within 4 weeks before the start of study administration and has not fully recovered;
• \. A large amount of pleural fluid or ascites accompanied by clinical symptoms or requiring symptomatic treatment;
• 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.
• \. 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);
• \. Heart failure classified by the New York College of Cardiology (NYHA) as grade 3 and above;
• \. 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;
• \. There are active or advanced infections that require systemic treatment, such as active tuberculosis;
• There are systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.;
• \. 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);
• \. 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);
• \. Have previously received allogeneic hematopoietic stem cell transplantation;
• \. Have received other antibody-conjugated drug therapy in the past;
• \. Those who are known to be allergic to recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent drugs and their components;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Lingying Wu

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingying Wu, M.D.

CONTACT

010-67781331; wulingying@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: December 21, 2021
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

CN (1)