EUCTR2018-003555-38-ES进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 193
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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.
- •a) SCCHN that has progressed following treatment with platinum-based chemotherapy for metastatic or recurrent disease, or progression of disease within 6 months of completing prior platinum therapy used as part of neoadjuvant, concurrent chemoradiation, or adjuvant therapy.
- •- Patients with upper esophageal or salivary gland tumors will not be considered as SCCHN.
- •- Patients who refuse radical resection for recurrent disease are eligible.
- •b) Locally advanced or metastatic TNBC that has progressed during or following at least one systemic therapy. ASCO CAP guidelines should be followed for establishing the diagnosis of triple-negative breast cancer.
- •c) mCRPC that has progressed during or following taxane chemotherapy, and if
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
- •bilirubin and without alternate etiology)
- •o = Grade 3 neurologic toxicity
- •o = Grade 3 colitis
- •o = Grade 3 pneumonitis
- •o = Grade 3 renal toxicity
- •5. Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer.
- •6. Treatment with any systemic chemotherapy within the 3 weeks prior to the initiation of study drug administration.
- •7. Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
- •8. Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
- •9. Clinically significant cardiovascular diseases.
- •10. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen use to maintain adequate oxygenation or history of = Grade 3 drug-induced or radiation pneumonitis.
- •11. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.
- •12. Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
- •13. Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction.
- •14. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
- •15. Second primary invasive malignancy that has not been in remission for greater than
- •2 years except non
研究者
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