A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors Cancer
• Interventions: Drug: ABBV-399

• Registration Number: NCT03311477
• Lead Sponsor: AbbVie

Brief Summary

An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Study Start: 2017-11-06
• Status Verified: 2019-03
• Primary Completion: 2019-03-04
• Study Completion: 2019-03-04
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Participant with histologically confirmed advanced solid tumor.
• Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
• Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
• Participant has adequate bone marrow, renal, and hepatic function.

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Exclusion Criteria

• Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, 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.
• Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-399.
• Participant has unresolved clinically significant adverse events >= Grade 2 from prior anticancer therapy except for alopecia or anemia.
• Participant has had major surgery within 21 days prior to the first dose of ABBV-399.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBV-399	ABBV-399	ABBV-399 via intravenous administration at escalating dose levels.

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)	Up to 24 months	AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399	Up to 21 days	MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Terminal elimination half life (t1/2)	Up to 24 months	Terminal elimination half life (t1/2)
Time to Cmax (Tmax)	Up to 24 months	Time to Cmax (Tmax)
Maximum Observed Concentration (Cmax)	Up to 24 months	Maximum observed concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	Up to 24 months	DOR is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first.
Progression-Free Survival (PFS) Time	Up to 24 months	PFS time is defined as the time from the participant's first dose of ABBV-399 to either the participant's disease progression or death, whichever occurs first.
Objective Response Rate (ORR)	Up to 24 months	Objective response rate (ORR) is defined as the proportion of participants with a confirmed partial or complete response to the treatment. Evaluation of tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Trial Locations

Locations (2)

National Cancer Center Hospital /ID# 166939; 🇯🇵 Chuo-ku, Tokyo, Japan

Shizuoka Cancer Center /ID# 166940; 🇯🇵 Sunto-gun, Shizuoka, Japan