A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors

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

Sponsors

Lead sponsor: AbbVie

Source 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.

Overall Status Completed
Start Date November 6, 2017
Completion Date March 4, 2019
Primary Completion Date March 4, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) Up to 24 months
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399 Up to 21 days
Terminal elimination half life (t1/2) Up to 24 months
Maximum Observed Concentration (Cmax) Up to 24 months
Time to Cmax (Tmax) Up to 24 months
Secondary Outcome
Measure Time Frame
Progression-Free Survival (PFS) Time Up to 24 months
Objective Response Rate (ORR) Up to 24 months
Duration of response (DOR) Up to 24 months
Enrollment 9
Condition
Intervention

Intervention type: Drug

Intervention name: ABBV-399

Description: Intravenous infusion

Arm group label: ABBV-399

Eligibility

Criteria:

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.

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.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Location
facility
Shizuoka Cancer Center /ID# 166940 | Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital /ID# 166939 | Chuo-ku, Tokyo, 104-0045, Japan
Location Countries

Japan

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ABBV-399

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov