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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
BT02
Drugmonoclonal antibody injection with intravenous administration every 2 or 3 weeks
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: dose escalation and expansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Time frame
Through the study completion, an average of 2 years2
Dose limited toxicity(DLT)
Time frame
Through the dose escalation phase, an average of 8 months3
Maximum tolerable dose(MTD)
Time frame
Through the dose escalation phase, an average of 8 months4
Recommended phase 2 dose(RP2D)
Time frame
Through the study completion, an average of 2 yearsSecondary outcomes
1
Objective response rate (ORR) on tumor assessments
Time frame
Through the study completion, an average of 2 years2
Progression-free survival (PFS) on tumor assessments
Time frame
Through the study completion, an average of 2 years3
Overall survival (OS)
Time frame
Through the study completion, an average of 2 years4
Duration of response (DoR) on tumor assessments
Time frame
Through the study completion, an average of 2 yearsLocations
Sponsors and contacts
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Biotroy Therapeutics
Lead sponsor
Peking University Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: