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

NCT07168083 | Not Yet Recruiting

• 1 other identifier: SYSKY-2025-526-01
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Ovarian Clear Cell Carcinoma; antibody-drug conjugate

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The proportion of patients whose tumor volume was reduced by more than 30% and maintained for 4 weeks

  2 years

Secondary Outcomes (3)

• Adverse event

  2 years

• Overall survival

  From enrollment to 2 years after treatment completion

• Progression free survival

  From enrollment to 2 years after treatment completion

Study Arms (1)

Sacituzumab Group

The patient received 5 mg/kg of Sacituzumab per two weeks.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolled patients with pathologically diagnosed OCCC who had progressed after treatment with immune checkpoint inhibitors, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received ruconazole (regardless of the number of lines of therapy received prior to immunotherapy).

You may qualify if:

• Histologically diagnosed ovarian clear cell carcinoma
• Patients who have progressed on imaging assessment after receiving immunotherapy, including anti-PD-1, PD-L1, and PD-1/PD-L1+CTLA4, and subsequently received Sacituzumab.
• At least one measurable lesion as assessed by RECIST, version 1.1.
• Life expectancy ≥ 12 months.
• Normal renal an liver function, no myelosuppression.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score (PS score) 0-1.
• Participants must be willing to participate in the study, be compliant, sign the informed consent form, and be able to adhere to protocol-specified visits and procedures.

You may not qualify if:

• Receipt of more than two lines of therapy after progression on immunotherapy.
• Previous use of irinotecan or ADCs containing topoisomerase I inhibitors.
• Presence or history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment
• Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that prevents delayed corneal healing.
• Concomitant incomplete or complete intestinal obstruction, intestinal fistula of any grade, hydronephrosis that cannot be resolved with a ureteral stent, inflammatory bowel disease or brain metastases.
• Organ transplant recipient.
• ≥ Grade 3 venous embolism
• Active infectious disease of any grade, including tuberculosis.
• Previous history of pelvic or abdominal radiation therapy to any site.
• Concurrent with other types of malignant tumors.
• Mental status abnormalities.
• Pregnant or lactating women; or patients of childbearing potential (male or female) who are unable to use effective medical contraception during the study period and for 6 months after the end of dosing.
• Any other condition deemed inappropriate for participation in this study by the investigator.

Sponsors & Collaborators

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

Related Publications (3)

• Takano M, Sugiyama T, Yaegashi N, Sakuma M, Suzuki M, Saga Y, Kuzuya K, Kigawa J, Shimada M, Tsuda H, Moriya T, Yoshizaki A, Kita T, Kikuchi Y. Low response rate of second-line chemotherapy for recurrent or refractory clear cell carcinoma of the ovary: a retrospective Japan Clear Cell Carcinoma Study. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):937-42. doi: 10.1111/j.1525-1438.2007.01158.x. Epub 2007 Dec 13.

  PMID: 18081792 BACKGROUND

• Sugiyama T, Kamura T, Kigawa J, Terakawa N, Kikuchi Y, Kita T, Suzuki M, Sato I, Taguchi K. Clinical characteristics of clear cell carcinoma of the ovary: a distinct histologic type with poor prognosis and resistance to platinum-based chemotherapy. Cancer. 2000 Jun 1;88(11):2584-9.

  PMID: 10861437 BACKGROUND

• Gadducci A, Multinu F, Cosio S, Carinelli S, Ghioni M, Aletti GD. Clear cell carcinoma of the ovary: Epidemiology, pathological and biological features, treatment options and clinical outcomes. Gynecol Oncol. 2021 Sep;162(3):741-750. doi: 10.1016/j.ygyno.2021.06.033. Epub 2021 Jul 8.

  PMID: 34247767 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

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

Study Officials

• Jing Li, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanan Lu, master

CONTACT

+8615868090553; luyn3@mail2.sysu.edu.cn

Jing Li, doctor

CONTACT

+8615915893493; lijing228@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 11, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share