Description:
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.
Title
- Brief Title: Study of AMV564 in Subjects With Advanced Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
AMV564-301
- NCT ID:
NCT04128423
Conditions
- Locally Advanced or Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
AMV564 | | AMV564 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
AMV564 | Experimental | | |
Eligibility Criteria
Key Inclusion Criteria:
- 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:
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Treatment-Related Adverse Events |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | As measured by the incidence, nature and severity of adverse events (AEs) and serious AEs |
Secondary Outcome Measures
Measure: | Maximum observed drug concentration (Cmax) of AMV564 |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | Measured by plasma concentration |
Measure: | Concentration at steady state (Css) of AMV564 |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | Measured by plasma concentration |
Measure: | Time of the maximum drug concentration (Tmax) of AMV564 |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | Measured by plasma concentration |
Measure: | Apparent terminal half-life (t½) of AMV564 |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | Measured by plasma concentration |
Measure: | Area under the concentration-time curve (AUC) of AMV564 |
Time Frame: | Through study completion, an average of 19 months |
Safety Issue: | |
Description: | Measured by plasma concentration |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Amphivena Therapeutics, Inc. |
Trial Keywords
- immunotherapy
- anti-CD33
- T-cell engager
Last Updated
May 14, 2021