Solid TumorPhase 1NCT02412462
Phase I Dose Escalation Study of AB-16B5 in Subjects With an Advanced Solid Malignancy
A Phase 1 study testing AB-16B5 in people with Solid Tumor and Metastatic Cancer, run by Alethia Biotherapeutics at 1 site in Canada.
Trial summary
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin (sCLU), a potent inducer of the epithelial-to-mesenchymal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Cancer
- What is being tested?
- AB-16B5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a histologically or cytologically confirmed advanced solid malignancy that has been refractory to prior therapy and is unlikely to benefit from known therapies.
- Subjects may have measurable or non-measurable but evaluable disease.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 and an estimated life expectancy of at least 12 weeks.
- Subjects must be ≥ 18 years old.
- Male, or female subjects who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile. Females of childbearing potential with a negative serum pregnancy test prior to entering the study and using adequate forms of contraception for the duration of the study, including 30 days after the last treatment. Males should avoid fathering children during the course of the study, and adequate methods of contraception should be used by both male and female subjects. Subjects and their partners with reproductive potential must use an effective contraceptive method while the subject is on the study treatment and for 30 days after the last treatment.
- Subjects must have adequate organ and immune function as indicated by the following laboratory values:
Show all 17Show fewer
- ANC ≥ 1.5 X 109/L
- Platelets > 100 X 109/L
- Hemoglobin ≥ 90 g/L
- Serum creatinine ≤ 132 µmol/L
- Total Bilirubin ≤ 1.5 X ULN
- AST (SGOT) and ALT (SGPT) ≤ 3 X ULN* or;
- 5 X ULN* (if hepatic metastases present)
- ULN: Institution's upper limit of normal
- Subjects enrolled in the standard dose escalation portion of the study must have a tumor lesion amenable for biopsy with no contraindications for biopsy.
- Subjects must understand and be able and willing and likely to fully comply with the study procedures, including scheduled follow-up, and restrictions.
- Subjects must have given written personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines, before completing any study related procedures.
Who cannot join
- Subjects with medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Prior cancer therapy including surgery, radiotherapy, chemotherapy, hormonal and biological therapies within 3 weeks prior to study treatment.
- Uncontrolled brain metastases.
- Uncontrolled infection.
- Clinically significant ECG abnormalities.
- Known hypersensitivity of Grade > 2 to previous monoclonal antibody therapy.
Show all 9Show fewer
- History of alcohol or other substance abuse within the last year.
- Use of another investigational agent in a clinical trial within the last 4 weeks prior to study treatment.
- Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening must be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AB-16B5 in Subjects With an Advanced Solid Malignancy
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects will have a disease that has been refractory to prior therapy and is unlikely to benefit from known therapies.
- Conditions
- Solid Tumor, Metastatic Cancer
- Being tested
- AB-16B5
- Keywords
- Phase I, Clusterin, Epithelial-to-Mesenchymal Transition (EMT), Circulating Tumor Cells (CTC), EMT and Stem Cell Biomarkers, Pharmacokinetics
- Medical subject headings
- Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-16B5Drug
| Study group | Role | What they receive |
|---|---|---|
| AB-16B5 | Experimental | Single-arm study of AB-16B5 given as a 60-minute intravenous weekly infusion. One cycle of treatment will consist of 21 days. The dose levels that will be assessed are 1.5, 3.0, 6.0, 9.0 and 12 mg/kg. Receives: Drug: AB-16B5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with an adverse event as a measure of safety and tolerability
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
Secondary outcomes (3)
Determination of plasma concentrations of AB-16B5
Measured: Several time-points during Cycle 1 and Cycle 2 for a total of 6 weeks
Objective tumor responses in subjects with measurable disease according to RECIST
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
Monitoring of epithelial-to-mesenchymal (EMT) and stem cells biomarkers in peripheral blood circulating tumor cells and paired tumor biopsies
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alethia Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412462
- Sponsor's protocol ID
- AB-16B5-101
- Status last verified
- Jul 2016
- First submitted
- 30 Mar 2015
- Last updated
- 28 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AB-16B5 in Subjects With an Advanced Solid Malignancy
- ClinicalTrials.gov ID
- NCT02412462
- Acronym / sponsor ID
- AB-16B5-101
- Conditions
- Solid Tumor, Metastatic Cancer
- Keywords
- Phase I, Clusterin, Epithelial-to-Mesenchymal Transition (EMT), Circulating Tumor Cells (CTC), EMT and Stem Cell Biomarkers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alethia BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Apr 2015 (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.
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics and pharmacodynamics of AB-16B5 in patients with an advanced solid malignancy. AB-16B5 is a humanized monoclonal antibody that inhibits the activity of the secreted form of clusterin (sCLU), a potent inducer of the epithelial-to-mesenchymal transition (EMT). Eligible subjects will have a disease that has been refractory to prior therapy and is unlikely to benefit from known therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB-16B5 | Experimental | Drug: AB-16B5Single-arm study of AB-16B5 given as a 60-minute intravenous weekly infusion. One cycle of treatment will consist of 21 days. The dose levels that will be assessed are 1.5, 3.0, 6.0, 9.0 and 12 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects with a histologically or cytologically confirmed advanced solid malignancy that has been refractory to prior therapy and is unlikely to benefit from known therapies.
- Subjects may have measurable or non-measurable but evaluable disease.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 and an estimated life expectancy of at least 12 weeks.
- Subjects must be ≥ 18 years old.
- Male, or female subjects who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile. Females of childbearing potential with a negative serum pregnancy test prior to entering the study and using adequate forms of contraception for the duration of the study, including 30 days after the last treatment. Males should avoid fathering children during the course of the study, and adequate methods of contraception should be used by both male and female subjects. Subjects and their partners with reproductive potential must use an effective contraceptive method while the subject is on the study treatment and for 30 days after the last treatment.
Key exclusion criteria (9 listed)
- Subjects with medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.
- Prior cancer therapy including surgery, radiotherapy, chemotherapy, hormonal and biological therapies within 3 weeks prior to study treatment.
- Uncontrolled brain metastases.
- Uncontrolled infection.
- Clinically significant ECG abnormalities.
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 |
|---|---|---|
| AB-16B5 | Drug | AB-16B5 |
Primary outcome
Number of participants with an adverse event as a measure of safety and tolerability
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
3 secondary outcomes
Determination of plasma concentrations of AB-16B5
Time frame: Several time-points during Cycle 1 and Cycle 2 for a total of 6 weeks
Objective tumor responses in subjects with measurable disease according to RECIST
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
Monitoring of epithelial-to-mesenchymal (EMT) and stem cells biomarkers in peripheral blood circulating tumor cells and paired tumor biopsies
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks
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 28 Jun 2017.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
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 AB-16B5 in people with Solid Tumor and Metastatic Cancer, run by Alethia Biotherapeutics at 1 site in Canada.
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 17 inclusion and 9 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 28 Jun 2017. 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 Canada. 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?
Number of participants with an adverse event as a measure of safety and tolerability (time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 6 to 24 weeks). 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 28 Jun 2017.