NCT03311477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

October 12, 2017

Last Update Submit

March 12, 2019

Conditions

Advanced Solid Tumors Cancer

Keywords

ABBV-399Maximum tolerated dose (MTD)Maximally administered dose (MAD)Dose escalationPharmacokineticsAdvanced solid tumorsCancerSolid tumors

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Progression-Free Survival (PFS) Time

    Up to 24 months

  • Objective Response Rate (ORR)

    Up to 24 months

  • Duration of response (DOR)

    Up to 24 months

Study Arms (1)

ABBV-399

EXPERIMENTAL

ABBV-399 via intravenous administration at escalating dose levels.

Drug: ABBV-399

Interventions

ABBV-399DRUG

Intravenous infusion

ABBV-399

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shizuoka Cancer Center /ID# 166940

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital /ID# 166939

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33675179DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

telisotuzumab vedotin

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

November 6, 2017

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)