NL-OMON51611已完成不适用
A Multicenter, Phase 1/1b Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors - M14-237
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must be >= 18 years of age
- •2. Subject must have advanced NSCLC that is not amenable to surgical resection
- •or other approved therapeutic options that have demonstrated clinical benefit.
- •-Subjects who have refused, are considered ineligible for or are intolerant of
- •standard therapy are eligible
- •-Based on evidence gathered in this study or from external sources, the Sponsor
- •in consultation with the Investigators, may decide to limit to specific tumor
- •- For Monotherapy dose-escalation - Subject with advanced solid tumors
- •- For Monotherapy dose-expansion and Combination Arms A + D - Subject must have
- •tumor with c-Met overexpression, MET exon 14 skip mutation or MET amplification.
- •3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status
- •of 0 to 2. For *monotherapy expansion cohort 1.6 Q2W*, subjects have an ECOG
- •performance status of 0 or 1.
- •4. Subject must have measurable disease per RECIST version 1.1 (Appendix C)
- •5. Subject has fresh and/or archived diagnostic formalin-fixed paraffin
- •embedded (FFPE) tumor tissue available for analysis
- •6. Subject has adequate bone marrow, renal, and hepatic function
- •7. A negative serum pregnancy test for all female subjects of childbearing
- •potential at the screening visit and a negative urine pregnancy test for all
- •female subjects of childbearing potential at baseline prior to the first dose
- •of study drug (for details on contraception refer to Section 5.2.1)
- •8. Subject is capable of understanding and complying with parameters as
- •outlined in the protocol and able to sign informed consent, approved by an
- •Institutional Review Board (IRB) prior to the initiation of any screening or
- •study-specific procedures.
- •Additional Inclusion Criteria for Subjects Enrolled on the Combination Therapy
- •Subjects in the combination therapy arms A and D must meet the above inclusion
- •criteria and be eligible to receive erlotinib, or nivolumab per locally
- •approved labeling, or at the discretion of the Investigator in consultation
- •with the Medical Monitor
- •-Subjects enrolled in the combination therapy phase Arm E must satisfy the
- •above inclusion criteria numbers 1 - 4, 6 - 8 and the following:
- •Subject must have metastatic/locally advanced nonsquamous NSCLC with
- •documented EGFR mutations del19 or L858R, with or without T790M mutation, and
- •none of the EGFR mutations known to be resistant to osimertinib.
- •Subject must have received at least 1 but no more than 2 prior regimens, one
- •of which must have contained osimertinib. Subject must have had disease
- •progression while on osimertinib. Only 1 prior regimen may have contained
- •chemotherapy. From amendment 15 and later, and for the purpose of this
- •eligibility criterion, consecutive EGFR TKIs will count as 1 regimen.
- •Subject must have available post-osimertinib progression tumor tissue for
- •central c-Met immunohistochemistry (IHC) testing. In cases where it is not
- •possible to obtain a post-osimertinib progression biopsy, archival tissue may
- •be allowed.
- •Additional Inclusion Criteria for Subjects Enrolled in the *monotherapy
- •expansion cohort 1.6 Q2W*
- •Subjects must satisfy the above inclusion criteria 1-4 , 6-8, and also the
- •Subjects must have locally advanced or metastatic, non-squamous, EGFR wild
- •type (site documented EGFR status), c-Met+ (as
排除标准
- •Subject has received radiation therapy to the lung < 6 months prior to the
- •first dose of ABBV-399.
- •Subject has received anticancer therapy including chemotherapy, immunotherapy,
- •biologic, or any investigational therapy within a period of 21 days, or herbal
- •therapy within 7 days prior to the first dose of ABBV-399.
- •-Palliative radiation therapy for bone or skin metastasis for 10 fractions or
- •less is not subject to a washout period; see below for central nervous system
- •metastatases (CNS).
- •-For approved targeted small molecules, a washout period of 5 half-lives is
- •adequate (no washout period is required for subjects currently on erlotinib or
- •osimertinib)
- •Subject has uncontrolled metastases to the CNS based on head CT or MRI.
- •Subjects with brain metastases may be eligible at least 2 weeks after
- •definitive therapy to all known sites of CNS disease provided they are
- •asymptomatic and either off or on a non-increasing dose (in last 2 weeks) of
- •systemic steroids and not on anticonvulsants for seizure activity directly
- •related to progressive CNS metastases.
- •Subjects with a history of interstitial lung disease (ILD) or pneumonitis
- •that required treatment with systemic steroids.
- •Subject has evidence of pulmonary fibrosis on screening imaging assessment or
- •any history of pneumonitis or interstitial lung disease (ILD) within 3 months
- •of the planned first dose of the study drug.
- •Subject has unresolved clinically significant adverse events >= Grade 2 from
- •prior anticancer therapy except for alopecia or anemia.
- •Subject has had major surgery within 21 days prior to the first dose of
- •ABBV-399.
- •Subject has a clinically significant condition(s)
- •Subject has history of major immunologic reaction to any IgG containing agent.
- •Subject has any medical condition which in the opinion of the Investigator or
- •Medical Monitor places the subject at an unacceptably high risk for toxicities.
- •Subject is a lactating or pregnant female.
- •Subjects with known active COVID-19 infection, subjects with signs/symptoms
- •associated with COVID-19 infection or known exposure to a confirmed case of
- •COVID-19 infection during 14 days prior to Screening: must be screen failed and
- •may only rescreen after they have recovered from COVID-19 or they are no longer
- •considered contagious, per investigator assessment.
- •Additional Exclusion Criteria for Subjects Enrolled on the Combination Therapy
- •Subjects enrolled on the combination therapy phase must satisfy the above
- •exclusion criteria and also the following:
- •-Subjects may not receive ABBV-399 in combination with osimertinib, erlotinib,
- •or nivolumab if they have any medical condition which in the opinion of the
- •Investigator places the subject at an unacceptably high risk for toxicities
- •from the combination.
- •Subjects may not receive nivolumab if they have * Active autoimmune disease
- •with exceptions of vitiligo, type I diabetes mellitus, hypothyroidism and
- •* Used systemic corticosteroids (> 10 mg daily prednisone or equivalent) or
- •other immunosuppressive medications within 14 days of study drug
- •administration, with exception of
- •inhaled, locally injected or topical steroids
- •* Known immunosuppressive disease, for example human immunodeficiency virus
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