RC48 in Combination With AK104 and Bevacizumab in OCCC

NCT06540729 | Recruiting Phase 2

• 1 other identifier: SYSKY-2024-532-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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)

Conditions

Ovary Cancer

Keywords

Disitamab vedotin; AK104; bevacizumab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate of advanced or recurrent ovarian clear cell carcinoma

  2 years

Secondary Outcomes (9)

• Time to progress

  2 years

• Adverse event

  2 years

• The time to the first subsequent therapy

  2 years

• Time to response

  2 years

• Duration of response

  2 years

Other Outcomes (1)

• Biomarker

  2 years

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer

Interventions

Disitamab vedotin in combination with AK104 and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer DRUG

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

Treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guanzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

disitamab vedotin; Bevacizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jing Li, doctor

CONTACT

15915893493; lijing228@mail.sysu.edu.cn

Miaofang Wu, doctor

CONTACT

13828494674; wmiaofang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: we are initiating this clinical study aimed at evaluating the efficacy and safety of vedolizumab (HER2-targeted ADC) in combination with AK104 (anti-PD-1 and CTLA4) and bevacizumab (anti-angiogenesis) in recurrent and persistent OCCC patients (vedolizumab 2.5 mg/kg + AK104 10 mg/kg + bevacizumab 15 mg/kg, every 3 weeks), with the aim of providing new treatment options for these refractory gynecologic malignancies.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 8, 2025

Record last verified: 2024-08

Locations

CN (1)