A Phase 1b, Open Label, Multicenter, Dose Escalation Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

This is an open-label, multicenter clinical trial designed to evaluate the safety and potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.

开始日期2017-08-31

申办/合作机构

AbbVie, Inc.

NCT02462525 / Terminated临床1期

A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

开始日期2015-05-06

申办/合作机构

AbbVie, Inc.

100 项与 Azintuxizumab vedotin 相关的临床结果

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100 项与 Azintuxizumab vedotin 相关的专利（医药）

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项与 Azintuxizumab vedotin 相关的文献（医药）

2020-05-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma.

1区 · 医学

Article

作者: Ravi Vij ; Rajneesh Nath ; Daniel E H Afar ; María-Victoria Mateos ; Jesús G Berdeja ; Marc S Raab ; Andreas Guenther ; Joaquín Martínez-López ; Andrzej J Jakubowiak ; Xavier Leleu ; Katja Weisel ; Shekman Wong ; Scott Gulbranson ; James P Sheridan ; Anita Reddy ; Bruno Paiva ; Anil Singhal ; Jesús F San-Miguel ; Philippe Moreau

PURPOSE:

ABBV-838 is an antibody-drug conjugate targeting a unique epitope of CD2 subset 1, a cell-surface glycoprotein expressed on multiple myeloma (MM) cells. This phase 1/1b first-in-human, dose-escalation study (Trial registration ID: NCT02462525) evaluated the safety, pharmacokinetics, and preliminary activity of ABBV-838 in patients with relapsed and refractory (RR) MM.

EXPERIMENTAL DESIGN:

Eligible patients (≥18 years) received ABBV-838 (3+3 design) intravenously starting from 0.6 mg/kg up to 6.0 mg/kg for 3-week dosing intervals (Q3W). Patients could continue ABBV-838 for up to 24 months. Assessment of alternate dosing intervals (Q1W and Q2W) were conducted in parallel.

RESULTS:

As of March 2017, 75 patients received at least one dose of ABBV-838. The most common any-grade treatment-emergent adverse events (TEAEs) were neutropenia and anemia (28.0% each), fatigue (26.7%), and nausea (25.3%). Grade 3/4/5 TEAEs were reported in 73.3% of patients across all treatment groups; most common were neutropenia (20.0%), anemia (18.7%), and leukopenia (13.3%). Grade 3/4/5 ABBV-838-related TEAEs were reported by 40.0% of patients across all treatment groups. Overall, 4.0% of patients experienced TEAEs leading to death, none ABBV-838 related. The maximum tolerated dose was not reached; the selected recommended dose for the expansion cohort was 5.0 mg/kg Q3W. Pharmacokinetic analysis showed that exposure was approximately dose proportional. The overall response rate was 10.7%; very good partial responses and partial responses were achieved by two (2.7%) and six (8.0%) patients, respectively.

CONCLUSIONS:

These results demonstrate that ABBV-838 is safe and well tolerated in patients with RR MM with a very limited efficacy.

100 项与 Azintuxizumab vedotin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14847

研发状态

适应症	最高研发状态	国家/地区	公司
多发性骨髓瘤	终止	美国更多	AbbVie, Inc. 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02462525 (Pubmed) 人工标引	临床1期	多发性骨髓瘤	75	ABBV-838	(衊壓糧顧淵鏇選繭獵願) = 齋艱壓膚窪鬱繭築膚築觸憲糧鬱願窪製鹽餘選 (衊艱願積製衊衊衊選製 ) 更多	积极	2020-05-15