Solid TumorsPhase 1NCT01603979
A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors
A Phase 1 study testing AV-203 in people with Solid Tumors, run by AVEO Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- AV-203
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Dec 2014
- 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
- ≥ 18 years of age
- Histologically and/or cytologically confirmed primary diagnosis
- Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
- Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Blood Chemistry and Hematology results within defined limits
Who cannot join
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
- Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
- Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
- Significant cardiovascular disease
- Significant thromboembolic or vascular disorders within prior 3 months
- Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
- Known history of positive results for hepatitis C, hepatitis B, or human immunodeficiency virus.
- For female subjects, pregnancy or lactation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AVEO Clinical Site
Atlanta, Georgia, 30322
AVEO Clinical Site
San Antonio, Texas, 78229
AVEO Clinical Site
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors
This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
- Conditions
- Solid Tumors
- Being tested
- AV-203
- Keywords
- AV203, Solid Tumors, ERBB3, Monoclonal Antibody, HER3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-203Biological
The antibody AV-203 is a humanized immunoglobulin G1/kappa (IgG1/κ) monoclonal antibody that targets the receptor tyrosine kinase (RTK) ERBB3 and inhibits ERBB3 activities. AV-203 will be administered as a 60 to 75-minute IV infusion once every 2 weeks until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation AV-203 Monotherapy | Experimental | dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks Receives: Biological: AV-203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)
Measured: Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days
Secondary outcomes (10)
Maximum Plasma Concentration (Cmax) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Time to Cmax (Tmax) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Area Under Plasma Concentration (AUC) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Terminal phase half-life (t1/2) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Clearance (Cl) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Volume of Distribution (Vd) of AV-203
Measured: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Objective Response Rate (ORR)
Measured: Within 28 days of first dose and every 8 weeks while on study
Disease Control Rate (DCR)
Measured: Within 28 days of first dose and every 8 weeks while on study
Duration of Response (DOR)
Measured: Within 28 days of first dose and every 8 weeks while on study
Time to Progression (TTP)
Measured: Within 28 days of first dose and every 8 weeks while on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603979
- Sponsor's protocol ID
- AV-203-12-101
- Status last verified
- Apr 2015
- First submitted
- 21 May 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01603979
- Acronym / sponsor ID
- AV-203-12-101
- Conditions
- Solid Tumors
- Keywords
- AV203, Solid Tumors, ERBB3, Monoclonal Antibody, HER3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 May 2012 (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, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation AV-203 Monotherapy | Experimental | Biological: AV-203dose-escalation of monotherapy AV-203 (an ERBB3 inhibitory antibody) by IV every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Histologically and/or cytologically confirmed primary diagnosis
- Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
- Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
Key exclusion criteria (8 listed)
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
- Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
- Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
- Significant cardiovascular disease
- Significant thromboembolic or vascular disorders within prior 3 months
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 |
|---|---|---|
| AV-203The antibody AV-203 is a humanized immunoglobulin G1/kappa (IgG1/κ) monoclonal antibody that targets the receptor tyrosine kinase (RTK) ERBB3 and inhibits ERBB3 activities. AV-203 will be administered as a 60 to 75-minute IV infusion once every 2 weeks until disease progression or unacceptable toxicity. | Biological | Dose-escalation AV-203 Monotherapy |
Primary outcome
Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)
Time frame: Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days
10 secondary outcomes
Maximum Plasma Concentration (Cmax) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Time to Cmax (Tmax) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Area Under Plasma Concentration (AUC) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Terminal phase half-life (t1/2) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Clearance (Cl) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Volume of Distribution (Vd) of AV-203
Time frame: pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose
Objective Response Rate (ORR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Disease Control Rate (DCR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Duration of Response (DOR)
Time frame: Within 28 days of first dose and every 8 weeks while on study
Time to Progression (TTP)
Time frame: Within 28 days of first dose and every 8 weeks while on study
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 8 Apr 2015.
Related trials for Solid Tumors
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.
3 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 AV-203 in people with Solid Tumors, run by AVEO Pharmaceuticals, Inc. at 3 sites in United States.
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 8 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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, SAEs and Dose-limiting Toxicities (DLTs) (time frame: Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days). 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 8 Apr 2015.