Locally Advanced or Metastatic Solid TumorsPhase 1NCT04128423
Study of AMV564 in Subjects With Advanced Solid Tumors
A Phase 1 study testing AMV564 in people with Locally Advanced or Metastatic Solid Tumors, run by Amphivena Therapeutics, Inc. at 11 sites in United States.
Trial summary
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- AMV564
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Oct 2019to 31 Dec 2021
- 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 or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
- Willing to complete all scheduled visits and assessments at the institution administering therapy
Who cannot join
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
- Major trauma or major surgery within 4 weeks prior to first dose of AMV564
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia
- Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45255
The Ohio State University
Columbus, Ohio, 43202
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
UCLA
Los Angeles, California, 90095
Peninsula Cancer Institute
Newport News, Virginia, 23601
Advent Health
Orlando, Florida, 32803
NEXT Oncology
San Antonio, Texas, 78229
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
Read the detailed description
AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.
- Being tested
- AMV564
- Keywords
- immunotherapy, anti-CD33, T-cell engager
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMV564Biological
AMV564 will be administered daily
| Study group | Role | What they receive |
|---|---|---|
| AMV564 | Experimental | Not described Receives: Biological: AMV564 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events
As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Measured: Through study completion, an average of 19 months
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
As determined based on the occurrence of dose-limiting toxicity
Measured: During Dose Escalation, an average of 6 months
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
As measured by the objective response rate (ORR)
Measured: During Dose Expansion, an average of 1 year
Secondary outcomes (5)
Maximum observed drug concentration (Cmax) of AMV564
Measured by plasma concentration
Measured: Through study completion, an average of 19 months
Concentration at steady state (Css) of AMV564
Measured by plasma concentration
Measured: Through study completion, an average of 19 months
Time of the maximum drug concentration (Tmax) of AMV564
Measured by plasma concentration
Measured: Through study completion, an average of 19 months
Apparent terminal half-life (t½) of AMV564
Measured by plasma concentration
Measured: Through study completion, an average of 19 months
Area under the concentration-time curve (AUC) of AMV564
Measured by plasma concentration
Measured: Through study completion, an average of 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start9 Oct 2019
- Primary completion15 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphivena Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Chun, MD, Study director, Amphivena Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128423
- Sponsor's protocol ID
- AMV564-301
- Status last verified
- May 2021
- First submitted
- 10 Oct 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04128423
- Acronym / sponsor ID
- AMV564-301
- Keywords
- immunotherapy, anti-CD33, T-cell engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Amphivena Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Oct 2019 (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.
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
Detailed description
AMV564-301 is a Phase 1, open-label, multicenter dose-escalation with expansion trial in patients with locally advanced or metastatic solid tumors. In the dose-escalation portion of the study, cohorts of patients will receive AMV564 alone or in combination with Pembrolizumab at increasing dose levels to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion. In the expansion portion of the study, one or more cohorts of patients will receive AMV564 at the MTD or recommended dose to further evaluate safety, tolerability, and clinical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMV564 | Experimental | Biological: AMV564 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
- Willing to complete all scheduled visits and assessments at the institution administering therapy
Key exclusion criteria (6 listed)
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
- Major trauma or major surgery within 4 weeks prior to first dose of AMV564
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia
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 |
|---|---|---|
| AMV564AMV564 will be administered daily | Biological | AMV564 |
Primary outcome
Incidence of Treatment-Related Adverse Events
Time frame: Through study completion, an average of 19 months
As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs
Maximum tolerated dose of AMV564 in subjects with advanced solid tumors
Time frame: During Dose Escalation, an average of 6 months
As determined based on the occurrence of dose-limiting toxicity
Preliminary evaluation of AMV564 efficacy in subjects enrolled in the expansion phase
Time frame: During Dose Expansion, an average of 1 year
As measured by the objective response rate (ORR)
5 secondary outcomes
Maximum observed drug concentration (Cmax) of AMV564
Time frame: Through study completion, an average of 19 months
Concentration at steady state (Css) of AMV564
Time frame: Through study completion, an average of 19 months
Time of the maximum drug concentration (Tmax) of AMV564
Time frame: Through study completion, an average of 19 months
Apparent terminal half-life (t½) of AMV564
Time frame: Through study completion, an average of 19 months
Area under the concentration-time curve (AUC) of AMV564
Time frame: Through study completion, an average of 19 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- 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.
Patrick Chun, MD study director
Amphivena Therapeutics
11 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 AMV564 in people with Locally Advanced or Metastatic Solid Tumors, run by Amphivena Therapeutics, Inc. at 11 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 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Results are not available in the source record.
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 Treatment-Related Adverse Events (time frame: Through study completion, an average of 19 months). The study lists 3 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 Oct 2021.