Prospective, Multicenter, Single-Arm, Phase Ⅱ Clinical Study on the Efficacy and Safety of Sacituzumab Tirumotecan Combined With Bevacizumab in Platinum-Resistant Recurrent Ovarian Cancer

NCT07314619 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB264-NSIP-032
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

As one of the gynecological malignancies with the highest incidence and mortality rates worldwide, ovarian cancer treatment faces the significant challenge of platinum-resistant recurrence. Patients with platinum-resistant recurrent ovarian cancer (PROC) have an extremely poor prognosis, and the survival benefits of traditional chemotherapy and bevacizumab combination therapy are limited (median progression-free survival \[mPFS\] is approximately 2-5 months, and 5-year survival rate is 30%-40%). In recent years, the antibody-drug conjugate (ADC) Sacituzumab tirumotecan has shown breakthrough potential. A phase Ⅱ study presented at the 2024 European Society for Medical Oncology (ESMO) Congress demonstrated that for patients with advanced platinum-resistant ovarian cancer (87.5% of whom had platinum resistance) treated with this drug as monotherapy, the objective response rate (ORR) reached 40%, median progression-free survival (mPFS) was 6.0 months, and disease control rate (DCR) was 75%. Furthermore, the ORR increased to 61.5% in patients with high Trop2 expression, and the safety profile was manageable.Based on the preclinical model evidence suggesting that anti-angiogenic drugs can enhance the intratumoral penetration of ADCs, the current study further explores the synergistic effect of Sacituzumab tirumotecan combined with bevacizumab. It aims to improve therapeutic efficacy by optimizing tumor microcirculation and analyze the molecular mechanisms using technologies such as organoids and single-cell sequencing, thereby providing a new strategy to overcome the bottleneck of platinum resistance.

Conditions

Platinum-resistant Recurrent Ovarian Cancer (PROC)

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.

  Up to 24 months

Secondary Outcomes (3)

• PFS

  Up to 24 months

• OS

  Up to 24 months

• Adverse Events (AEs)

  Up to 24 months

Other Outcomes (1)

• Correlation between Trop2 expression, TMB level, immune cell subsets, tumor microenvironment, etc. in tumor tissues and therapeutic efficacy

  Up to 24 months

Study Arms (1)

Sacituzumab tirumotecan combined with bevacizumab

EXPERIMENTAL

Drug: Sacituzumab Tirumotecan Combined with Bevacizumab

Interventions

Sacituzumab Tirumotecan Combined with Bevacizumab DRUG

Sacituzumab Tirumotecan is administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, and is given once on Day 1 of each cycle. Bevacizumab is administered at a dose of 7.5\~15 mg/kg via intravenous infusion, once every 3 weeks. Treatment is continued until disease progression or the occurrence of intolerable toxicity.

Sacituzumab tirumotecan combined with bevacizumab

Eligibility Criteria

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

You may qualify if:

• Sign a written informed consent form before undergoing any trial-related procedures;
• Female, aged ≥ 18 years;
• Histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; with platinum resistance (recurrence within 6 months after the last platinum dose);
• Enrolled subjects must have received at least one but no more than three prior systemic treatment regimens, and the prior regimens may include bevacizumab and/or poly(ADP-ribose) polymerase inhibitors (PARPi);
• For subjects with brain metastases, only those with asymptomatic or symptomatically stable brain metastases are eligible for enrollment;
• ECOG performance status score of 0-1;
• Expected survival time \> 6 months;
• Adequate organ function, with subjects required to meet the following laboratory parameters:
• Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days;
• Platelet count ≥ 100×10⁹/L without blood transfusion within the past 14 days;
• Hemoglobin \> 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days;
• Total bilirubin ≤ 1.5×Upper Limit of Normal (ULN);
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN;
• Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min;
• Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN;

You may not qualify if:

• Diagnosis of other malignant diseases within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ with radical resection);
• Known presence of active bleeding signs in lesions as shown by endoscopy;
• Currently participating in therapeutic intervention clinical research, or having received other study drugs or treatment with study devices within 4 weeks before the first dose;
• Previous receipt of the following therapies: ADC drugs targeting FR-α, or TROP2-targeted treatments (such as any drug therapy containing topoisomerase I targeting agents, including antibody-drug conjugate (ADC) therapy);
• Systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose;
• Occurrence of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment;
• Receipt of systemic glucocorticoid therapy (excluding nasal spray, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Use of physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) is permitted;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Known hypersensitivity to the drugs used in this study;
• Failure to fully recover from toxicity and/or complications caused by any intervention (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia) before the start of treatment;
• Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies);
• Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal of the laboratory in the research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: a) HBV viral load \< 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV treatment throughout the study chemotherapy period to prevent viral reactivation; b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary;
• Subjects with active HCV infection (positive HCV antibodies and HCV-RNA level above the lower limit of detection);
• Receipt of live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Receipt of inactivated viral vaccines for seasonal influenza via injection within 30 days before the first dose is permitted; however, intranasal attenuated live influenza vaccines are not allowed;
• Pregnant or lactating women;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Interventions

Bevacizumab

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

Xie Ya

CONTACT

Professor; wangxinxin058@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)