Status:
UNKNOWN
Study of AMV564 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Amphivena Therapeutics, Inc.
Conditions:
Locally Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 tumo...
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04128423
Start Date
October 9 2019
End Date
December 31 2021
Last Update
October 19 2021
Active Locations (11)
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1
UCLA
Los Angeles, California, United States, 90095
2
Advent Health
Orlando, Florida, United States, 32803
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Northwestern University
Chicago, Illinois, United States, 60611