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Clinical Trial NCT06540729 (DAB) for Ovary Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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RC48 in Combination With AK104 and Bevacizumab in OCCC (DAB) Phase 2 39
Clinical Trial NCT06540729 (DAB) is designed to study Treatment for Ovary Cancer. It is a Phase 2 interventional study that is recruiting, having started on 24 September 2024, with plans to enroll 39 participants. Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, it is expected to complete by 1 August 2030. The latest data from ClinicalTrials.gov was last updated on 8 July 2025.
Brief Summary
Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer: a single-arm, phase II, multicenter study (DAB OCC study)
Detailed Description
Ovarian clear cell carcinoma (OCCC) ranks as the second most common epithelial ovarian malignancy in Asian women, characterized by extremely poor prognosis, with a median overall survival (OS) of 25.3 months. OCCC demonstrates a dismal response rate to conventional chemotherapy, and once in a state of persistence or recurrence, treatments become severely limited, with a mere 5-year survival rate of 13.2%, with over t...Show More
Official Title
Disitamab Vedotin (RC48) in Combination With AK104 (PD-1/CTLA-4 Bispecific) and Bevacizumab for the Treatment of Recurrent and Persistent Clear Cell Ovarian Cancer
Conditions
Ovary CancerOther Study IDs
- DAB
- SYSKY-2024-532-01
NCT ID Number
Start Date (Actual)
2024-09-24
Last Update Posted
2025-07-08
Completion Date (Estimated)
2030-08-01
Enrollment (Estimated)
39
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Disitamab vedotin
AK104
bevacizumab
AK104
bevacizumab
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreatment Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer | Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate | Objective response rate of advanced or recurrent ovarian clear cell carcinoma | 2 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to progress | Time to progress of advanced or recurrent ovarian clear cell carcinoma | 2 years |
Adverse event | Adverse event rate of treatment with RC48 in combination with AK104 and bevacizumab | 2 years |
The time to the first subsequent therapy | The time to the first subsequent therapy for enrolled patients | 2 years |
Time to response | Time to response for enrolled patients | 2 years |
Duration of response | Duration of response of advanced or recurrent ovarian clear cell carcinoma | 2 years |
Disease control rate | Disease control rate of patients with recurrent or advanced ovarian clear cell carcinoma receiving intervention | 2 years |
Progression free survival | Progression free survival of enrolled patients with recurrent or advanced ovarian clear cell | 2 years |
Overall survival | Overall survival of enrolled patients with recurrent or advanced ovarian clear cell | 2 years |
Eastern Cooperative oncology group performance status score | ECOG score of enrolled patients | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- The pathological diagnosis confirms ovarian clear cell carcinoma. In cases of mixed carcinoma, a prerequisite is that clear cell carcinoma constitutes at least 70% of the tumor mass. Moreover, adherence to RECIST 1.1 criteria mandates the presence of at least one evaluable lesion.
- HER2 IHC ≥1+.
- Treatment-naïve individuals encompass those experiencing tumor progression during postoperative chemotherapy and those who, following platinum-containing neoadjuvant chemotherapy, have not undergone surgical intervention yet and subsequently manifested progression during or after platinum-containing chemotherapy, provided that they have received a maximum of 2 prior lines of chemotherapy.
- Recurrent patients, whether platinum-sensitive or platinum-resistant, include those lacking a platinum-free interval of ≥6 months and who, post-recurrence, have undergone re-administration of platinum-containing chemotherapy but have demonstrated an inability to tolerate toxic reactions, with a maximum of 2 lines of chemotherapy post-recurrence.
- Previous utilization of bevacizumab is permissible.
- Adequate bone marrow reserve function necessitates pre-operative blood routine parameters meeting specific criteria: white blood cell count ≥3.0×10^9/L, neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, and hemoglobin ≥80 g/L.
- atisfactory organ function entails biochemical test results within defined limits: AST ≤2.5× upper limit of normal (ULN), ALT ≤2.5× ULN, serum total bilirubin ≤1.5× ULN, and creatinine ≤1.5× ULN.
- ECOG performance status score ranging from 0 to 1.
- Patient participation is contingent upon voluntary execution of an informed consent form.
- Patients with a history of immunotherapy, including treatments targeting PD-1, PD-L1, CAR-T, and CTLA-4.
- Patients diagnosed with other malignancies within the past five years, excluding skin cancer and thyroid cancer.
- Patients with an expected survival of ≤12 weeks.
- Patients with a known allergy to taxane-based medications.
- Patients who, based on clinical assessment, have contraindications for receiving immunotherapy and/or bevacizumab, such as uncontrolled infections, gastrointestinal fistula, autoimmune diseases, active hepatitis, or active bleeding.
Patients currently undergoing treatment with investigational anti-cancer drugs in other clinical trials.
- Patients with any unstable condition or situation that may compromise their safety or adherence to the study protocol.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityStudy Central Contact
Contact: Jing Li, doctor, 15915893493, [email protected]
Contact: Miaofang Wu, doctor, 13828494674, [email protected]
1 Study Locations in 1 Countries
Guangdong
Sun Yat-sen Memorial Hospital, Guanzhou, Guangdong, 510120, China
Jing Li, Doctor, Contact, +8615915893493, [email protected]
Recruiting