A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
Doma Biopharmaceutical（Suzhou）Co., Ltd.
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.
Description
This first-in-human (FIH), multicenter, open-label, dose escalation and dose expansion study is to evaluate the safety, preliminary efficacy and pharmacokinetic (PK) characteristics of DM005 monotherapy in participants with advanced solid tumors. DM005, a bispecific ADC developed using fully human antibodies with a common light chain, which targets c-MET and EGFR. Subjects with solid malignant tumors will be treated with DM005 on Day 1 once Q3W (dose adjustments may be required depending on the safety profile and PK data of each dose
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Parti…
Interventions
- DrugDM005
An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W.
Locations (6)
- Henry Ford Cancer InstituteDetroit, Michigan
- Sarah Cannon Research Institute at Mary CrowleyDallas, Texas
- NEXT Oncology VirginiaFairfax, Virginia
- Chris O'Brien LifehouseCamperdown, New South Wales
- Macquarie University HospitalNorth Ryde, New South Wales
- ICON Cancer CenterSouth Brisbane, Queensland