NCT07738757尚未招募2 期
A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With Tagitanlimab (KL-A167) as Second-Line or Later Therapy for MSI-H/dMMR Advanced Gynecological Malignancies: An Open-Label, Single-Arm, Multicenter Exploratory Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
This is a prospective, open-label, multicenter, single-arm Phase II study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT/SKB264) in combination with tagitanlimab (KL-A167) as second-line or later therapy in patients with recurrent or metastatic MSI-H/dMMR gynecological malignancies, including endometrial cancer, ovarian cancer, and cervical cancer. The primary objective is to evaluate the objective response rate (ORR) per RECIST v1.1 as assessed by the investigator. Secondary objectives include evaluating overall survival (OS), progression-free survival (PFS) per RECIST v1.1, disease control rate (DCR), duration of response (DoR), and the safety and tolerability of the combination regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Age ≥18 years.
- •2. Histologically or cytologically confirmed recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.
- •3. dMMR or MSI-H subtype (defined as: deficiency/loss of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, or MSH6 expression detected by immunohistochemistry (IHC), or identified as MSI-H by polymerase chain reaction (PCR)/next-generation sequencing (NGS)).
- •4. Received at least 1 prior systemic regimen (prior anti-PD-1/L1 allowed) for recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •6. Life expectancy more than 12 weeks.
- •7. At least one measurable lesion per RECIST 1.1 criteria.
- •8. Subjects must have recovered from all toxicities related to prior therapies, except for toxicities not considered a safety risk.
- •9. Adequate function of the important organs.
- •10. For female subjects of childbearing potential effective medical contraception must be used from the time of signing the informed consent form until 6 months after the last dose of the drug.
- •11. Participants must voluntarily participate in the study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up assessments.
排除标准
- •1. Subjects with known other malignant tumors that are progressing or require active treatment within the past 3 years.
- •2. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases. Subjects with locally treated brain metastases may participate provided they are clinically stable for at least 4 weeks, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
- •3. Subjects with clinically significant cardiovascular diseases.
- •4. Subjects with severe and/or uncontrolled concomitant diseases, such as uncontrolled hypertension, symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- •5. Subjects diagnosed with active hepatitis B or active hepatitis C.
- •6. Subjects with known uncontrolled HIV infection.
- •7. Subjects with known active tuberculosis.
- •8. Subjects with documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal disorders that impair or delay corneal healing.
- •9. Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or who have not recovered from prior surgery.
- •10. Subjects with known hypersensitivity or anaphylaxis to the study drug or its excipients; or a history of severe hypersensitivity reactions to monoclonal antibodies.
- •11. Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently suffering from ILD/pneumonia, or unable to rule out suspected ILD/pneumonia through imaging at screening.
- •12. Subjects with a history of allogeneic tissue/organ transplantation.
- •13. Subjects with autoimmune diseases requiring systemic treatment within the past 2 years or requiring immunosuppressive treatment during the study period. Subjects with controllable type 1 diabetes, thyroiditis with normal thyroid function, or hypothyroidism well controlled by hormone replacement therapy (HRT), or skin diseases (such as vitiligo, psoriasis) that do not require systemic treatment can be included.
- •14. Subjects who have previously received TROP2-targeted drugs or any therapy containing a topoisomerase I inhibitor, including antibody-drug conjugates (ADCs).
- •15. Subjects who have previously used any experimental anti-tumor vaccines.
- •16. Subjects who received live vaccines within 30 days prior to the first dose of study treatment or plan to receive live vaccines during the study.
- •17. Subjects who need to use strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first study treatment and during the study period.
- •18. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of study treatment; subjects who received small molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormone therapy, systemic immunostimulants (including but not limited to interferon, IL-2), or approved anti-tumor Chinese herbal preparations within 2 weeks before the first study treatment.
- •19. Subjects who received systemic anti-infective treatment within 2 weeks prior to the first dose of study treatment.
- •20. Pregnant or lactating women.
- •21. Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study.
研究组 & 干预措施
Cohort 1: Endometrial cancer
Experimental
干预措施: Tagitanlimab (Drug)
Cohort 2: Ovarian cancer & Cervical cancer
Experimental
干预措施: Tagitanlimab (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: up to 24 months
Ãbjective Response Rate (ÃRR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR). assessed byInvestigator based on RECiST version 1.1.
次要结局
- Progression-free survival(PFS)(up to 24 months)
- Duration of response (DoR)(up to 24 months)
- Disease control rate(DCR)(up to 24 months)
- Overall survival(OS)(up to 5 years)
- Incidence and severity of adverse events (AEs)(up to 24 months)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial TumorsNCT07343453Sun Yat-sen University38
尚未招募
2 期
A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.Advanced Biliary Tract CancersNCT07729033Tianjin Medical University Cancer Institute and Hospital28
尚未招募
2 期
Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLCExtensive-Stage Small Cell Lung CancerNCT07388875China Medical University, China30
尚未招募
3 期
Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA MutationsNCT07628504Fudan University420
尚未招募
2 期
Sacituzumab Tirumotecan Plus Immunotherapy for Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaRecurrent or Metastatic Head and Neck CarcinomaNCT07686588Biying Chen20