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Advanced Solid Tumors CancerPhase 1NCT03311477

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

A Phase 1 study testing ABBV-399 in people with Advanced Solid Tumors Cancer, run by AbbVie at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
ABBV-399
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesJapan
Study dates
6 Nov 2017to 4 Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center Hospital /ID# 166939

    Chuo-ku, Tokyo, 104-0045

  • Shizuoka Cancer Center /ID# 166940

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

About this study

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

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

Being tested
ABBV-399
Keywords
ABBV-399, Maximum tolerated dose (MTD), Maximally administered dose (MAD), Dose escalation, Pharmacokinetics, Advanced solid tumors, Cancer, Solid tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-399Drug

    Intravenous infusion

Study groups in NCT03311477
Study groupRoleWhat they receive
ABBV-399ExperimentalABBV-399 via intravenous administration at escalating dose levels.
Receives: Drug: ABBV-399

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Up to 21 days

  3. Terminal elimination half life (t1/2)

    Terminal elimination half life (t1/2)

    Measured: Up to 24 months

  4. Maximum Observed Concentration (Cmax)

    Maximum observed concentration (Cmax)

    Measured: Up to 24 months

  5. Time to Cmax (Tmax)

    Time to Cmax (Tmax)

    Measured: Up to 24 months

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start6 Nov 2017
  3. Primary completion4 Mar 2019
  4. Study completion4 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311477
Sponsor's protocol ID
M16-080
Status last verified
Mar 2019
First submitted
12 Oct 2017
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-399 in people with Advanced Solid Tumors Cancer, run by AbbVie at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) (time frame: Up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311477, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.

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