Efficacy and Safety of Sacituzumab in Patients With OCCC After Immunotherapy Progression

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT07168083
Status
Not Yet Recruiting

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Conditions

  • Antibody-drug Conjugates
  • Clear Cell Adenocarcinoma of Ovary
  • Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Study Details

Ovarian clear cell carcinoma (OCCC) is a relatively rare but highly malignant epithelial ovarian cancer, accounting for 5%-10% of all ovarian cancers. The incidence of this tumor has significant racial disparity, with the highest incidence in Asians, accounting for 25% of ovarian cancer patients, while in European and American ovarian cancer patients, it only accounts for 4.8%. Due to the unique biological behavior of OCCC, it responds poorly to traditional platinum-based chemotherapy regimens, and the prognosis of patients with advanced and recurrent disease is extremely poor. OCCC has low sensitivity to platinum-based chemotherapy, especially in recurrent or persistent disease, and the objective response rate (ORR) of chemotherapy is usually less than 10%. Although immunotherapy has shown good results in OCCC, 60% of patients still cannot shrink their tumors after using combination regimens, and 50% of patients will still progress after 6.9 months of treatment. The question of how to treat OCCC after progression on immunotherapy remains a pressing issue. Sacituzumab (SKB264) is an antibody-drug conjugate (ADC) consisting of a humanized anti-trophoblast cell surface antigen 2 (Trop-2) monoclonal antibody conjugated to T030. In the KL264-I-01 study (which included patients with OCCC) in patients with recurrent ovarian cancer, single-agent Sacituzumab achieved an objective response rate of 40%, superior to conventional chemotherapy, with manageable toxicity. OCCC patients who progress on immunotherapy face a dilemma of limited treatment options. Based on this current situation and the potential activity of Sacituzumab the investigators propose Sacituzumab as an option for patients with OCCC after immunotherapy progression.

Key Dates

First listed
Sep 11, 2025
Start date
Sep 1, 2026
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
22 participants (estimated)

Arms

  • Arm: Sacituzumab Group
    The patient received 5 mg/kg of Sacituzumab per two weeks.

Primary Outcome Measure

Objective response rate [ Time Frame: 2 years ]

Central Contacts

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