Advanced CancerPhase 1NCT02884726
Phase 1 Study of Mesothelin-ADC
A Phase 1 study testing BMS-986148 in people with Advanced Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- BMS-986148
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- 14 Oct 2016to 6 Sep 2017
- 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
- Must have histological confirmation of advanced and/or metastatic solid
- tumors which are expected to express mesothelin
- Must have received and either progressed or been intolerant to the standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Who cannot join
- Cancer metastases in the brain
- Uncontrolled or significant cardiovascular disease
- Moderate eye disorders
- Moderate peripheral neuropathy
- Known past or active hepatitis B or C infection
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- BMS-986148
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986148Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986148 intravenous infusion | Experimental | Not described Receives: Drug: BMS-986148 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs (Adverse Events)
AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Measured: Day 1 to 30 days after the last dose of BMS-986148
Incidence of SAEs (Serious Adverse Events)
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Measured: Day 1 to 30 days after the last dose of BMS-986148
Grade of AEs
AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Measured: Day 1 to 30 days after the last dose of BMS-986148
Grade of SAEs
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Measured: Day 1 to 30 days after the last dose of BMS-986148
Secondary outcomes (15)
Maximum observed concentration (Cmax)
Measured: Day 1 to day 84
Time of maximum observed concentration (Tmax)
Measured: Day 1 to day 84
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Measured: Day 1 to day 84
Area under the concentration-time curve in one dosing interval [AUC(TAU)]
Measured: Day 1 to day 84
Average concentration (Cavg)
Measured: Day 1 to day 84
Half life (T-half)
Measured: Day 1 to day 84
Trough observed plasma concentration (Ctrough)
Measured: Day 1 to day 84
Concentration in a dosing interval (Ctau)
Measured: Day 1 to day 84
Total body clearance (CLT)
Measured: Day 1 to day 84
Apparent volume of distribution at steady state (Vss)
Measured: Day 1 to day 84
Volume of distribution of terminal phase (Vz)
Measured: Day 1 to day 84
AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)
Measured: Day 1 to day 84
Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)
Measured: Day 1 to day 84
Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)
Measured: Day 1 to day 84
Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Day 1 to 30 days after the last dose of BMS-986148
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start14 Oct 2016
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884726
- Sponsor's protocol ID
- CA008-008
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT02884726
- Acronym / sponsor ID
- CA008-008
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 31 Aug 2016 (estimated)
- 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.
The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic 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 |
|---|---|---|
| BMS-986148 intravenous infusion | Experimental | Drug: BMS-986148 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have histological confirmation of advanced and/or metastatic solid
- tumors which are expected to express mesothelin
- Must have received and either progressed or been intolerant to the standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Key exclusion criteria (6 listed)
- Cancer metastases in the brain
- Uncontrolled or significant cardiovascular disease
- Moderate eye disorders
- Moderate peripheral neuropathy
- Known past or active hepatitis B or C infection
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 |
|---|---|---|
| BMS-986148Specified dose on specified days | Drug | BMS-986148 intravenous infusion |
Primary outcome
Incidence of AEs (Adverse Events)
Time frame: Day 1 to 30 days after the last dose of BMS-986148
AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Incidence of SAEs (Serious Adverse Events)
Time frame: Day 1 to 30 days after the last dose of BMS-986148
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of AEs
Time frame: Day 1 to 30 days after the last dose of BMS-986148
AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of SAEs
Time frame: Day 1 to 30 days after the last dose of BMS-986148
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
15 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Day 1 to day 84
Time of maximum observed concentration (Tmax)
Time frame: Day 1 to day 84
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: Day 1 to day 84
Area under the concentration-time curve in one dosing interval [AUC(TAU)]
Time frame: Day 1 to day 84
Average concentration (Cavg)
Time frame: Day 1 to day 84
Half life (T-half)
Time frame: Day 1 to day 84
Trough observed plasma concentration (Ctrough)
Time frame: Day 1 to day 84
Concentration in a dosing interval (Ctau)
Time frame: Day 1 to day 84
Total body clearance (CLT)
Time frame: Day 1 to day 84
Apparent volume of distribution at steady state (Vss)
Time frame: Day 1 to day 84
Volume of distribution of terminal phase (Vz)
Time frame: Day 1 to day 84
AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)
Time frame: Day 1 to day 84
Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)
Time frame: Day 1 to day 84
Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)
Time frame: Day 1 to day 84
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Day 1 to 30 days after the last dose of BMS-986148
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 19 Mar 2020.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986148 in people with Advanced Cancer, run by Bristol-Myers Squibb at 1 site 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 5 inclusion and 6 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of AEs (Adverse Events) (time frame: Day 1 to 30 days after the last dose of BMS-986148). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2020.