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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors Cancer
• Intervention / Treatment: Drug: ABBV-399

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 166940
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 166939

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-399; ABBV-399 via intravenous administration at escalating dose levels.	Drug: ABBV-399; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)	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.	Up to 24 months
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399	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.	Up to 21 days
Terminal elimination half life (t1/2)	Terminal elimination half life (t1/2)	Up to 24 months
Maximum Observed Concentration (Cmax)	Maximum observed concentration (Cmax)	Up to 24 months
Time to Cmax (Tmax)	Time to Cmax (Tmax)	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Time	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.	Up to 24 months
Objective Response Rate (ORR)	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.	Up to 24 months
Duration of response (DOR)	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.	Up to 24 months

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, Yonemori K, Ocampo C, Parikh A, Okubo S, Fukasawa K, Murakami H. Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Cancer Med. 2021 Apr;10(7):2350-2358. doi: 10.1002/cam4.3815. Epub 2021 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): March 4, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Solid tumors; Pharmacokinetics; Dose escalation; ABBV-399; Maximum tolerated dose (MTD); Advanced solid tumors; Maximally administered dose (MAD)
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: M16-080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No