NCT06723236招募中1 期
A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- MacroGenics
- 入组人数
- 124
- 试验地点
- 13
- 主要终点
- Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
研究概览
简要总结
The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
- What types of side effects will participants experience when receiving MGC028?
- Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors?
Participants will
- Undergo screening procedures to determine eligibility
- Receive study treatments initially every 3 weeks.
- Have blood samples taken for routine and research tests
- Have other examinations to check heart and lung function, and general health status
- Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.
- Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
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
- •Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.
- •Participants in expansion cohorts must have either
- •NSCLC adenocarcinoma with
- •progression on or following anti-PD-1/PD-L1 inhibitor, unless contraindicated
- •progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present
- •no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.
- •Pancreatic cancer
- •following at least 1 systemic therapy
- •no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.
- •Colorectal adenocarcinoma with
- •Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable
- •Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H/dMMR, if present.
- •No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease
- •No more than 4 lines of systemic regimens for advanced or metastatic disease
- •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.
- •Active brain metastases or leptomeningeal metastases.
- •Prior stem cell, tissue, or solid organ transplant.
- •Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score < 6), or carcinoma in situ.
- •Active viral, bacterial, or fungal infection
- •Prior treatment with ADAM9 targeted agent for cancer.
- •Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.
研究组 & 干预措施
Cohort 1
Experimental
Dose level 1 of MGC028, IV
干预措施: MGC028 (Biological)
Cohort 2
Experimental
Dose level 2 of MGC028, IV
干预措施: MGC028 (Biological)
Cohort 3
Experimental
Dose level 3 of MGC028, IV
干预措施: MGC028 (Biological)
Cohort 4
Experimental
Dose level 4 of MGC028, IV
干预措施: MGC028 (Biological)
Cohort 5
Experimental
Dose level 5 of MGC028, IV
干预措施: MGC028 (Biological)
Cohort 6
Experimental
Dose level 6 of MGC028, IV
干预措施: MGC028 (Biological)
Expansion Cohort 1
Experimental
MTD or MAD of MGC028, IV
干预措施: MGC028 (Biological)
Expansion Cohort 2
Experimental
MTD or MAD of MGC028, IV
干预措施: MGC028 (Biological)
Expansion Cohort 3
Experimental
MTD or MAD of MGC028, IV
干预措施: MGC028 (Biological)
结局指标
主要结局
Number and Types of Adverse Events (AEs) in Participants Receiving MGC028
时间窗: Throughout the study treatment and safety follow up period, up to 25 months
Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study
次要结局
- Mean maximum concentration of MGC028 antibody(Through Cycle 6 of the study, approximately 18 weeks)
- Mean Area Under the Concentration Time Curve of MGC028 antibody(Through Cycle 6 of the study, approximately 18 weeks)
- Number of Participants Who Develop Anti-Drug Antibodies to MGC028(Throughout the study treatment period, up to 2 years)
- Objective Response Rate (ORR)(Throughout the study and follow up period, up to 2.5 years.)
- Median Duration of Response(Throughout the study and follow up period, up to 2.5 years.)
- Mean maximum concentration of MGC028 free payload(Through Cycle 6 of the study, approximately 18 weeks)
- Mean Area Under the Concentration Time Curve Total exposure of MGC028 payload(Through Cycle 6 of the study, approximately 18 weeks)
- Change from baseline in the level of ADAM9 expression in tumor specimens, using immunohistochemistry(Baseline and approximately 28 days after the first dose of MGC028.)
研究者
研究点 (13)
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