A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Solid Tumors

MacroGenics, Inc.0 个研究点目标入组 193 人2019年7月4日

适应症Advanced Solid Tumors MedDRA version: 20.0 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10036921 Term: Prostate carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10030052 Term: Ocular melanomas System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Advanced Solid Tumors
发起方: MacroGenics, Inc.
入组人数: 193
状态: 进行中（未招募）
最后更新: 6年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2019年7月4日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

MacroGenics, Inc.

入排标准

入选标准

•1\. Ability to provide informed consent and documentation of informed consent prior to initiation of any study\-related tests or procedures that are not part of standard\-of\-care for the patient’s disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
•2\. Age \= 18 years old.
•3\. Archival tissue or FFPE tissue must be available for B7\-H3 and PD\-L1 (testing on all patients enrolled). Tumor specimens for determination of B7\-H3 and PD\-L1 expression via IHC staining will be collected on all patients during both Dose Escalation and Cohort Expansion, and will be assayed at a central laboratory designated by the Sponsor. Determination of B7\-H3 and PD\-L1 IHC testing results will not be required prior to protocol enrollment. Prior B7\-H3 testing results may be accepted at the discretion of the Sponsor to satisfy this requirement. Patients may undergo a fresh tumor biopsy to obtain a specimen for testing if a suitable sample cannot be identified.
•4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
•5\. Life expectancy \= 12 weeks.
•6\. Measurable disease as per RECIST v1\.1 criteria (Appendix 5\) and documented by CT and/or MRI. Patients with mCRPC without measurable disease (bone disease only) may be enrolled during the Dose Escalation Phase. Cutaneous or subcutaneous lesions must be measurable by calipers. Note: Lesions to be used as measurable disease for the purpose of response assessment must either a) not reside in a field that has been subjected to prior radiotherapy or b) have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment.
•7\. Tumor Histology Types
•Dose Escalation Portion of the Study
•a) Patients with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic solid tumors of any histology for whom no approved therapy with demonstrated clinical benefit is available. For alltumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first\-line therapy.
•Cohort Expansion Portion of the Study: Patients with histologically proven, unresectable, locally advanced or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available as described below. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard therapy.

排除标准

•1\. Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment:
•o No concurrent treatment for the CNS disease (e.g., surgery, radiation,
•corticosteroids \> 10 mg prednisone/day or equivalent)
•o No progression of CNS metastases on MRI or CT for at least 21 days after last day of prior therapy for the CNS metastases
•o No concurrent leptomeningeal disease or cord compression
•2\. Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave’s disease that are now euthyroid clinically and by laboratory testing.
•3\. Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration.
•4\. Previous Checkpoint Inhibitor Therapy: Patients who experienced the following immune checkpoint inhibitor\-related AEs make the patient ineligible despite the AE resolving to \= Grade 1 or baseline:
•o \= Grade 3 ocular AE
•o Changes in liver function tests that met the criteria for Hy's Law (\> 3 × ULN of either ALT/AST with concurrent \> 2 × ULN of total