Advanced Solid Tumors Cancer
Conditions
Keywords
ABBV-399, Maximum tolerated dose (MTD), Maximally administered dose (MAD), Dose escalation, Pharmacokinetics, Advanced solid tumors, Cancer, Solid tumors
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.
Interventions
DRUGABBV-399
Intravenous infusion
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cmax (Tmax) | Up to 24 months | Time to Cmax (Tmax) |
| Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399 | Up to 21 days | 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. |
| Terminal elimination half life (t1/2) | Up to 24 months | Terminal elimination half life (t1/2) |
| Maximum Observed Concentration (Cmax) | Up to 24 months | Maximum observed concentration (Cmax) |
| Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) | Up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 24 months | 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. |
| Duration of response (DOR) | Up to 24 months | 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. |
| Progression-Free Survival (PFS) Time | Up to 24 months | 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. |
Countries
Japan
Outcome results
None listed