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

NCT ID: NCT07168083

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2029-08-31

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.

Detailed Description

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%. The OCCC tumor microenvironment indicates that OCCC is a "hot tumor," suggesting that patients may benefit from immunotherapy. This benefit has been confirmed in clinical studies. 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.

The investigators plan to conduct a prospective, real-world clinical study to enroll patients with OCCC who have developed resistance to immunotherapy and receive Sacituzumab (5 mg/kg intravenous infusion, 2 weeks of treatment). The investigators will prospectively observe and collect treatment responses, efficacy data, and safety events, and compare the efficacy with that of a historical cohort of immunotherapy-resistant patients who received traditional chemotherapy.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sacituzumab Group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Jing Li

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Yanan Lu, master

Role: CONTACT

luyn3@mail2.sysu.edu.cn

+8615868090553

Jing Li, doctor

Role: CONTACT

lijing228@mail.sysu.edu.cn

+8615915893493

References

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.

Reference Type: BACKGROUND

PMID: 18081792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10861437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34247767 (View on PubMed)

Other Identifiers

SYSKY-2025-526-01

Identifier Type: -

Identifier Source: org_study_id