RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression

NCT06420973 | Recruiting Phase 2

• 1 other identifier: RCVDODIIR017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.

Conditions

Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.

  Up to approximately 2 years

Secondary Outcomes (4)

• Objective Response Rate（ORR）

  Up to approximately 2 years

• Disease Control Rate (DCR)

  Up to approximately 2 years

• Overall Survival（OS）

  Up to approximately 2 years

• Number of Participants With Adverse Events (AEs)

  Up to approximately 2 years

Study Arms (1)

RC48+carboplatin±bevacizumab

EXPERIMENTAL

RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy.

Drug: RC48+carboplatin±bevacizumab

Interventions

RC48+carboplatin±bevacizumab DRUG

RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy.

RC48+carboplatin±bevacizumab

Eligibility Criteria

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

You may qualify if:

• Female subjects aged from 18 to 75 years old;
• Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma;
• Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
• Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
• Estimated life expectancy of more than 3 months;
• Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）
• Adequate haematological, hepatic and renal functions defined by the protocol;
• Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for female subjects if the risk of conception exists;

You may not qualify if:

• The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer or metastatic ovarian cancer;
• The patient has ≥ grade 2 peripheral neuropathy;
• Patients with active bleeding or pathological conditions with high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders, or tumors involving large blood vessels;
• Suffering from central nervous system metastasis and/or cancerous meningitis. Except for stable brain metastases; 5.The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hair loss);
• Patients who require parenteral hydration or nutrition and have evidence of partial intestinal obstruction or perforation;
• Except for patients with primary endometrial cancer or a history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-B stage; No more than superficial muscle infiltration, no vascular or lymphatic infiltration; No poorly differentiated subtypes, including papillary fluid, clear cells, or other FIGO grade 3 lesions;
• For patients undergoing cell reduction surgery before treatment, if combined with bevacizumab, they must wait for at least 28 days before starting the treatment with bevacizumab;
• Have undergone major surgery within 4 weeks prior to the start of study administration and have not fully recovered;
• A large amount of pleural or ascitic fluid accompanied by clinical symptoms or requiring symptomatic treatment;
• Within 30 days of initial medication or expected to receive attenuated live vaccines during the study period;
• Serious arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents that occurred within one year prior to drug administration were studied;
• There are systemic diseases that have not been controlled stably according to the judgment of the researcher, including diabetes, liver cirrhosis (Child Pugh Class B or C), interstitial pneumonia, obstructive pulmonary disease, etc;
• Clinically significant cardiovascular disease patients(According to the specific requirements of the plan);
• Individuals with active autoimmune diseases or immunodeficiency, or a history of the aforementioned conditions, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., shall not be included. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study;
• Subjects with a history of other malignant tumors within five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma skin cancer);

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Hong Zheng

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube 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; Fallopian Tube Diseases

Central Study Contacts

Hong Zheng, M.D.

CONTACT

86-010-88196100; zhhong306@hotmail.com

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: M.D.

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 20, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)