Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer

NCT06574763 | Not Yet Recruiting Phase 2

• 1 other identifier: B2024-318-01
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this phase II single arm prospective clinical study is to evaluate the efficacy and toxicity of RC48 plus carboplatin neoadjuvant therapy in HER2 expressed epithelial ovarian cancer patients. The main questions it aims to answer are:

• The improvement of complete resection rate and pathological complete rate of this regimen.
• The delayed effect of treatment regimens on patient's recurrence.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Completed Resection Rate

  Completed Resection Rate (CRR): Complete tumor resection is defined as the absence of gross residual intra-abdominal and pelvic lesions assessed by the investigator during interval debulking surgery after the patient has received neoadjuvant therapy. The CRR is the percentage of patients achieving complete tumor resection.

  3-month

Secondary Outcomes (5)

• Pathologic complete response

  3-month

• Objective Response Rate (ORR)

  3-month

• Progression Free Survival (PFS)

  3-year

• Adverse Event Rate

  from the first day of treatment till 30 days after discontinuing the medication

• Overall survival

  5-year

Study Arms (1)

RC48+Carboplatin

EXPERIMENTAL

Drug: RC48/Carboplatin

Interventions

RC48/Carboplatin DRUG

RC48, 2.5mg/kg, iv, Q3W Carboplatin, AUC 5, iv, D1, Q3W

RC48+Carboplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- General criteria:
• Voluntarily consent to participate in the study and sign an informed consent form.
• Age 18-75 years (at the time of signing consent).
• Expected survival ≥ 12 months.
• ECOG performance status 0 or 1.
• Body weight must be \>30 kg.
• Able to understand trial requirements and willing and able to adhere to trial and follow-up procedures.
• Women of childbearing potential (defined as not having undergone surgical sterilization or not having naturally menstruated for at least 12 consecutive months) must agree to use effective contraception during the study treatment.
• \- Tumor-related criteria:
• Newly diagnosed, histologically or cytologically confirmed FIGO stage III-IV high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• HER2 expression: including patients with HER2 immunohistochemistry (IHC) results of IHC 1+ or higher and gene amplification detected by ERBB2 testing.
• Physical condition unsuitable for direct surgery or imaging or laparoscopic assessment indicating low likelihood of achieving complete resection through direct surgery.
• Patients must have at least one measurable lesion according to RECIST v1.1 criteria (assessed by the investigator).
• \- Adequate organ function: Criteria met within 28 days prior to the first dose of Cycle 1:
• Bone marrow function:

You may not qualify if:

• \- Tumor-related criteria:
• Histologic types of endometrioid carcinoma, clear cell carcinoma, mucinous carcinoma, or sarcomatoid tumors, including any mixed tumors with these types, or low-grade/borderline ovarian tumors.
• Known active central nervous system (CNS) metastases and/or leptomeningeal disease.
• Presence of pleural effusion, pericardial effusion, or ascites that cannot be controlled through drainage or other methods.
• \- Comorbidities and medical history:
• Severe clinically significant active infections.
• History of multiple sclerosis (MS) or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
• Significant clinically relevant heart disease, including but not limited to:
• Myocardial infarction within ≤ 6 months prior to first dose;
• Unstable angina;
• Uncontrolled congestive heart failure (\> II grade);
• Uncontrolled hypertension (≥ 3 grade per CTCAE criteria);
• Uncontrolled arrhythmias.
• Cerebrovascular accident (CVA), transient ischemic attack (TIA), or intracranial hemorrhage (e.g., brain hemorrhage, subarachnoid hemorrhage, or subdural hemorrhage) within 6 months prior to enrollment.
• ECG showing clinically significant abnormal results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Jundong Li, Dr.

CONTACT

13602859866; lijd@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 28, 2024

Record last verified: 2024-08