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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors Cancer

Treatments

Drug: ABBV-399

Study type

Interventional

Funder types

Industry

Identifiers

NCT03311477

M16-080

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

All

Ages

20+ years old

Volunteers

No 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.