Locally Advanced or Metastatic Solid Tumors
Conditions
Keywords
immunotherapy, anti-CD33, T-cell engager
Brief 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.
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.
Interventions
BIOLOGICALAMV564
AMV564 will be administered daily
Sponsors
Amphivena Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Related Adverse Events | 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 | 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 | During Dose Expansion, an average of 1 year | As measured by the objective response rate (ORR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent terminal half-life (t½) of AMV564 | Through study completion, an average of 19 months | Measured by plasma concentration |
| Maximum observed drug concentration (Cmax) of AMV564 | Through study completion, an average of 19 months | Measured by plasma concentration |
| Area under the concentration-time curve (AUC) of AMV564 | Through study completion, an average of 19 months | Measured by plasma concentration |
| Concentration at steady state (Css) of AMV564 | Through study completion, an average of 19 months | Measured by plasma concentration |
| Time of the maximum drug concentration (Tmax) of AMV564 | Through study completion, an average of 19 months | Measured by plasma concentration |
Countries
United States
Outcome results
None listed