A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBiotroy Therapeutics
About this trial
The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with advanced melanoma,regardless of gender, aged between 18 and 75 years (inclusive).
Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.
Eligibility criteria
Qualifiers
Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy .
Adequate organ and hematologic function.
At least 1 extracranial measurable lesion.
An ECOG activity status score of 0-1.
Disqualifiers
Prior to first dose, received systemic antitumor therapy , scheduled major surgical procedure within 4 weeks , received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
A history of active autoimmune disease within the past 2 years.
A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities or LVEF<50%. A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
A severe acute or chronic infection when enrollment.
Trial design
Treatments tested in this trial
- BT02
Treatment groups
58 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Biotroy Therapeutics
Lead sponsor
Peking University Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov