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

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

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

Conditions
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Advanced Solid Tumors Cancer

Intervention / Treatment
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* Drug: ABBV-399


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBV-399<br>ABBV-399 via intravenous administration at escalating dose levels. | Drug: ABBV-399<br>* Intravenous infusion<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-399, Maximum tolerated dose (MTD), Maximally administered dose (MAD), Dose escalation, Pharmacokinetics, Advanced solid tumors, Cancer, Solid tumors