A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- MacroGenics
- 入组人数
- 80
- 试验地点
- 24
- 主要终点
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
研究概览
简要总结
Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.
Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.
Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR
- •Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.
- •Persistent or recurrent disease with documented disease progression.
- •Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
- •Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
- •Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.
- •Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.
- •Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
- •Participants have acceptable physical condition and laboratory values.
- •Participants of childbearing potential must agree to use highly effective methods of birth control.
- •Participants must not be pregnant, planning to be pregnant, or breastfeeding.
排除标准
- •Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- •Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.
- •Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.
- •Active brain metastases or leptomeningeal metastases.
- •Prior stem cell, tissue, or solid organ transplant.
- •Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.
- •Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.
研究组 & 干预措施
Cohort B (CCGC)
Lorigerlimab 6 mg/kg IV every 21 days
干预措施: Lorigerlimab (Biological)
Cohort C (CCGC)
Lorigerlimab 3 mg/kg IV every 21 days
干预措施: Lorigerlimab (Biological)
Cohort A (PROC) high dose
Lorigerlimab 6 mg/kg IV every 21 days
干预措施: Lorigerlimab (Biological)
Cohort A (PROC) low dose
Lorigerlimab 3 mg/kg IV every 21 days
干预措施: Lorigerlimab (Biological)
结局指标
主要结局
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
时间窗: Throughout the study up to approximately 2 years
The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
次要结局
- Median duration of response (DoR) per RECIST 1.1 criteria(Throughout the study, up to approximately 2.5 years)
- Median progression free survival (PFS) per RECIST 1.1 criteria(Throughout the study, up to 2.5 years)
- Percent change from baseline in tumor size(Throughout the study, up to 2.5 years)
- Best percent change from baseline in tumor size(Throughout the study, up to 2.5 years)
- Disease control rate (DCR)(Throughout the study, up to 2.5 years)
- Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.(Throughout the study, up to approximately 2 years)