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Ovarian CancerPhase 2NCT06574763

Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer

A Phase 2 study testing RC48/Carboplatin in people with Ovarian Cancer, run by Sun Yat-sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
RC48/Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 1 Sep 2026
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • Hemoglobin ≥ 90 g/dL Absolute neutrophil count ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L
  • Liver function (normal values as defined by the clinical trial center):
  • Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN) In the absence of liver metastases, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 × ULN; with liver metastases, ALT, AST, and ALP ≤ 5 × ULN
  • Renal function (normal values as defined by the clinical trial center):
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min (Cockcroft-Gault formula) Urinalysis showing urinary protein ≥ 3+ should be followed by a 24-hour urine collection with 24-hour urinary protein < 3.5 g
  • Coagulation function:
  • International normalized ratio (INR) ≤ 1.5 or 2.5 (for patients receiving anticoagulation therapy) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
  • Cardiac function:
  • New York Heart Association (NYHA) classification < Grade 3

Who cannot join

  • 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.
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  • 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.
  • History of clinically diagnosed and currently active non-infectious interstitial lung disease (ILD), including non-infectious pneumonia, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or other severe pulmonary diseases.
  • History of liver cirrhosis (Child-Pugh class C).
  • History of abdominal wall fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months prior to randomization.
  • Bleeding disorders or significant coagulation abnormalities (in the absence of anticoagulation).
  • Major surgery within 4 weeks prior to enrollment (except for exploratory procedures performed at other institutions).
  • Non-healing wounds, active ulcers, or fractures.
  • History of other primary malignancies, except for those with minimal risk of metastasis or death.
  • Concurrent treatments:
  • Previous treatment with Vedicimab or other HER2-targeted therapies.
  • Prior anti-cancer treatment for ovarian cancer, including chemotherapy, immunotherapy, or targeted therapy; patients may receive concurrent hormone therapy (e.g., hormone replacement therapy) or bisphosphonates for non-cancer-related conditions.
  • Other:
  • Known hypersensitivity to monoclonal antibody therapy, MMAE class drugs, or any component of the study drug.
  • Pregnant or breastfeeding women.
  • Investigator believes the subject has other severe systemic diseases or conditions that make participation in the clinical study inappropriate.

Trial locations and contacts

No sites are listed yet.

Jundong Li, Dr. contact

13602859866 ext. 086

lijd@sysucc.org.cn

About this study

Official title: Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer: a Prospective Phase 2 Exploratory Study

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.
Read the detailed description

The current standard treatment for newly diagnosed ovarian cancer involves a combination of surgery, chemotherapy, and adjuvant therapy. Ovarian cancer surgery is challenging and has a high incidence of postoperative complications. Many studies have explored the use of neoadjuvant therapy before surgery to shrink tumors and downstage the disease, aiming to increase the proportion of operable patients and the rate of complete resection, while also reducing surgical difficulty and associated risks. Guidelines recommend that neoadjuvant chemotherapy for high-grade serous ovarian cancer should be consistent with the first-line chemotherapy regimen, with paclitaxel/carboplatin every three weeks being the preferred regimen in clinical practice.

However, there are still unmet needs in neoadjuvant chemotherapy for ovarian cancer: 1. The rate of pathologic complete response (pCR) after neoadjuvant chemotherapy is less than 10%, yet achieving pCR significantly improves prognosis; 2. Using the same regimen for neoadjuvant chemotherapy and postoperative chemotherapy may lead to the development of subsequent chemotherapy resistance, thereby shortening the time before the patient develops platinum resistance; 3. Neoadjuvant chemotherapy can have severe adverse reactions.

RC48 (Disitamab Vedotin) is a human epidermal growth factor 2 (HER2)-directed antibody-drug conjugate, with a novel humanized anti-HER2 antibody disitamab conjugated to monomethyl auristatin E (MMAE) via a cleavable linker. This study used RC48 combined with carboplatin to explore the efficacy and toxic side effects of this regimen as neoadjuvant therapy in epithelial ovarian cancer patients.

Conditions
Ovarian Cancer
Being tested
RC48/Carboplatin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC48/CarboplatinDrug

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

Study groups in NCT06574763
Study groupRoleWhat they receive
RC48+CarboplatinExperimentalNot described
Receives: Drug: RC48/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-month

Secondary outcomes (5)

  1. Pathologic complete response

    percentage of patients who achieved complete response

    Measured: 3-month

  2. Objective Response Rate (ORR)

    Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 3 cycles, ie ORR=CR+PR

    Measured: 3-month

  3. Progression Free Survival (PFS)

    Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first

    Measured: 3-year

  4. Adverse Event Rate

    The Adverse Event Rate is defined as the percentage of patients who experience any Adverse Events (AE), Serious Adverse Events (sAE), and Treatment-Related Adverse Events (TEAEs) from the first day of treatment till 2 years after discontinuing the medication

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

  5. Overall survival

    OS is defined as the time from the study enrollment to death due to any cause.

    Measured: 5-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

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
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06574763
Sponsor's protocol ID
B2024-318-01
Status last verified
Aug 2024
First submitted
22 Aug 2024
Last updated
28 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48/Carboplatin in people with Ovarian Cancer, run by Sun Yat-sen University.

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 29 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Jundong Li, Dr. (13602859866 ext. 086, lijd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completed Resection Rate (time frame: 3-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574763.

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 28 Aug 2024.

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