A Study of DM005 in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.
Eligibility Criteria
Inclusion Criteria: * Common inclusion criteria for both Parts 1. Participants must have the ability to understand and willingness to sign a written informed consent document. 2. Participants who have pathologically or cytologically documented metastatic/advanced NSCLC, gastroesophageal cancer, CRC, HCC, pancreatic cancer, or HNSCC, not curable with standard local therapies (i.e., surgery and/or radiation) and have progressed on standard therapy, or intolerant to standard therapy. 3. Participants must be ≥18 years of age on the day of signing the informed consent form (ICF). 4. Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2. 5. Has a life expectancy ≥3 months. 6. Has measurable disease based on response evaluation criteria in solid tumors (RECIST) version 1.1. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: 1. Participants have another active invasive malignancy within 5 years, w