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CompletedNCT03311477Updated Mar 14, 2019

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

A Phase 1 interventional study of ABBV-399 in Advanced Solid Tumors Cancer, sponsored by AbbVie. Completed at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by AbbVie · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors Cancer

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Keywords

  • ABBV-399
  • Maximum tolerated dose (MTD)
  • Maximally administered dose (MAD)
  • Dose escalation
  • Pharmacokinetics
  • Advanced solid tumors
  • Cancer
  • Solid tumors
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    ABBV-399

    ABBV-399 via intravenous administration at escalating dose levels.

    Drug: ABBV-399

Interventions

  • DrugABBV-399

    Intravenous infusion

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 24 months

  2. 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.

    Time frame: Up to 21 days

  3. Terminal elimination half life (t1/2)

    Terminal elimination half life (t1/2)

    Time frame: Up to 24 months

  4. Maximum Observed Concentration (Cmax)

    Maximum observed concentration (Cmax)

    Time frame: Up to 24 months

  5. Time to Cmax (Tmax)

    Time to Cmax (Tmax)

    Time frame: Up to 24 months

Secondary outcomes

  1. 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.

    Time frame: Up to 24 months

  2. 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.

    Time frame: Up to 24 months

  3. 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.

    Time frame: Up to 24 months

06

Study locations

2 sites
  • Shizuoka Cancer Center /ID# 166940
    Sunto-gun, Shizuoka 411-8777, Japan
  • National Cancer Center Hospital /ID# 166939
    Chuo-ku, Tokyo 104-0045, Japan
07

References and documents

Publications

  • 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. PubMed 33675179 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03311477
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Nov 6, 2017
Primary completion
Mar 4, 2019
Completion
Mar 4, 2019
Last update
Mar 14, 2019

Study contacts

AbbVie Inc.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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