NCT05194072终止1 期
A Phase 1 Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 250
- 试验地点
- 27
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease.
This study is seeking for participants who either have cancer:
- that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable),
- has spread through the body (metastatic), or have some cancer left over after surgery.
This study will have five parts.
- Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants.
- Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers.
- Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab.
- Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Parts A, B, and C:
- •Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types:
- •High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- •HER2-negative, HR positive breast cancer
- •Triple-negative breast cancer (TNBC)
- •Endometrial carcinoma
- •Non-small cell lung cancer (Squamous cell carcinoma [SqCC], Adenocarcinoma [AC])
- •Cholangiocarcinoma or gallbladder carcinoma
- •Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC.
- •For Part E:
- •Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing
- •Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS<10 by local testing
- •Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery
- •Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option
- •Part C: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies.
- •Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC
- •Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC
- •Tumor tissue is required for enrollment.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).
排除标准
- •History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- •Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
- •are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
- •have no new or enlarging brain metastases
- •and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
- •Carcinomatous meningitis
- •Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
- •Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- •Corneal disease or injury requiring treatment or active monitoring
研究组 & 干预措施
Felmetatug Vedotin (Parts A, B, and C)
Experimental
Felmetatug Vedotin monotherapy
干预措施: Felmetatug Vedotin (Drug)
Felmetatug Vedotin and Pembrolizumab (Parts D and E)
Experimental
Felmetatug Vedotin in combination with Pembrolizumab.
干预措施: Felmetatug Vedotin (Drug)
Felmetatug Vedotin and Pembrolizumab (Parts D and E)
Experimental
Felmetatug Vedotin in combination with Pembrolizumab.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Through 30 days after last study treatment, up to approximately 5 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
时间窗: Through 30-37 days after last study treatment, up to approximately 5 years
Number of participants with dose limiting toxicities (DLTs)
时间窗: Up to 28 days
Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level
时间窗: Through 30-37 days after last study treatment; up to approximately 5 years
次要结局
- Confirmed objective response rate (ORR) by investigator assessment(Up to approximately 5 years)
- Complete response rate (CRR)(Up to approximately 5 years)
- Duration of response (DOR)(Up to approximately 5 years)
- Progression-free survival (PFS)(Up to approximately 5 years)
- Invasive disease-free survival (iDFS)(Up to approximately 5 years)
- Pharmacokinetic (PK) parameter - Area under the curve (AUC)(Through 30-37 days after last study treatment; up to approximately 3 years)
- PK parameter - Maximum concentration (Cmax)(Through 30-37 days after last study treatment, up to approximately 3 years)
- PK parameter - Time to maximum concentration (Tmax)(Through 30-37 days after last study treatment, up to approximately 3 years)
- PK parameter - Apparent terminal half-life (t1/2)(Through 30-37 days after last study treatment, up to approximately 3 years)
- PK parameter - Trough concentration (Ctrough)(Through 30-37 days after last study treatment, up to approximately 3 years)
- Incidence of antidrug antibodies (ADAs)(Through 30-37 days after last study treatment, up to approximately 3 years)
研究者
研究点 (27)
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