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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression

A Single-arm, Multicenter, Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer

RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression (NCT06420973) is a Phase 2 interventional studying Ovarian Carcinoma and Fallopian Tube Carcinoma, sponsored by Peking University Cancer Hospital & Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 54 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovarian Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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; Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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; Exclusion Criteria: * 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); * Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 2000 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; * Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (\>38.5%) of unknown reason occurred during the screening period/before the first administration; * Currently participating in intervention clinical research treatment, or receiving other investigational drugs or research instruments within 4 weeks prior to the first administration; Not fully recovered from toxicity and/or complications caused by any intervention measures prior to initial administration (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss); * Has a clear history of allergies and may have potential allergies or intolerance to the investigational drug and its similar biological agents; * Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;

Treatments Being Tested

DRUG

RC48+carboplatin±bevacizumab

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hong Zheng
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06420973), the sponsor (Peking University Cancer Hospital & Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06420973 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06420973?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06420973?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06420973. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06420973. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.