What is the Purpose of this Study?
Primary Objective: Phase 1 Dose Escalation: 1. To determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) of AVZO-1418 as monotherapy and in combination therapy 2. To characterize the safety and tolerability of AVZO-1418 as monotherapy and in combination therapy Phase 2 Dose Expansion 1. To assess the antitumor activity of AVZO-1418 as monotherapy and in combination therapy using RECIST v1.1 Secondary Objectives: Phase 1 Dose Escalation: 1. To assess preliminary antitumor activity of AVZO-1418, as monotherapy and in combination therapy using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 2. To characterize the PK of AVZO-1418, total antibody, and free payload (P1021) Phase 2 Dose Expansion: 1. To confirm the RP2D of AVZO-1418 in selected tumor types as monotherapy and in combination therapy 2. To further characterize the antitumor activity of AVZO-1418 as monotherapy and in combination therapy using RECIST v1.1 3. To further characterize the safety and tolerability of AVZO-1418 4. To further characterize PK of AVZO-1418, total antibody, and free payload when given as monotherapy and in combination therapy 5. To assess the immunogenicity of AVZO-1418
Eligibility
- * Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months.
- * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
- o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).
Where can I participate?
- CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
- CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan
More about this Clinical Trial
What is the full name of this clinical trial?
AVZO-1418-1001: A phase 1/2, first-in-human study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of AVZO-1418 as a single agent and in combination therapy in patients with locally advanced or metastatic solid tumors