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

NCT03311477•AbbVie

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Shizuoka Cancer Center /ID# 166940

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 166939

Chuo-ku, Tokyo, Japan

Key Dates

Start Date

November 6, 2017

Primary Completion Date

March 4, 2019

Completion Date

March 4, 2019

Last Updated

March 14, 2019

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumors Cancer

Interventions

ABBV-399

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGPHASE1/PHASE2

A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

NCT07259590

Advanced Solid Tumors CancerPDAC+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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