Clinical trial NCT03311477: A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors Cancer
Keywords: ABBV-399
Maximum tolerated dose (MTD)
Maximally administered dose (MAD)
Dose escalation
Pharmacokinetics
Advanced solid tumors
Cancer
Solid tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
timeFrame: Up to 24 months
measure: Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
timeFrame: Up to 21 days
measure: Terminal elimination half life (t1/2)
timeFrame: Up to 24 months
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to 24 months
measure: Time to Cmax (Tmax)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) Time
timeFrame: Up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 months
measure: Duration of response (DOR)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 166940
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 166939
state: Tokyo
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.