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.
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
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.
- Conditions
- Advanced Solid Tumors Cancer
- 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 group | Role | What they receive |
|---|---|---|
| ABBV-399 | Experimental | ABBV-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.
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
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
Terminal elimination half life (t1/2)
Terminal elimination half life (t1/2)
Measured: Up to 24 months
Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax)
Measured: Up to 24 months
Time to Cmax (Tmax)
Time to Cmax (Tmax)
Measured: Up to 24 months
Secondary outcomes (3)
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
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
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.
- First posted17 Oct 2017
- Study start6 Nov 2017
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03311477
- Acronym / sponsor ID
- M16-080
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-399 | Experimental | Drug: ABBV-399ABBV-399 via intravenous administration at escalating dose levels. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-399Intravenous infusion | Drug | ABBV-399 |
Primary outcome
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Time frame: 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.
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
Time frame: 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)
Time frame: Up to 24 months
Terminal elimination half life (t1/2)
Maximum Observed Concentration (Cmax)
Time frame: Up to 24 months
Maximum observed concentration (Cmax)
Time to Cmax (Tmax)
Time frame: Up to 24 months
Time to Cmax (Tmax)
3 secondary outcomes
Progression-Free Survival (PFS) Time
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Duration of response (DOR)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Derived from this study: PubMed 33675179Fujiwara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
2 sites in 1 country: see every site and its status.
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.