Not yet recruiting NCT07107178
A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BT02.
- Who it may be relevant to
- Registry conditions: Advanced Melanoma, Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib Study of the Safety, Tolerability and Efficacy of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
Overview
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.
Interventions
- Drug BT02
monoclonal antibody injection with intravenous administration every 2 or 3 weeks
Primary outcome measures
- Adverse events [Time frame: Through the study completion, an average of 2 years]
- Dose limited toxicity(DLT) [Time frame: Through the dose escalation phase, an average of 8 months]
- Maximum tolerable dose(MTD) [Time frame: Through the dose escalation phase, an average of 8 months]
- Recommended phase 2 dose(RP2D) [Time frame: Through the study completion, an average of 2 years]
Secondary outcome measures (8)
- Objective response rate (ORR) on tumor assessments [Time frame: Through the study completion, an average of 2 years]
- Progression-free survival (PFS) on tumor assessments [Time frame: Through the study completion, an average of 2 years]
- Overall survival (OS) [Time frame: Through the study completion, an average of 2 years]
- Duration of response (DoR) on tumor assessments [Time frame: Through the study completion, an average of 2 years]
- Disease control rate (DCR) on tumor assessments [Time frame: Through the study completion, an average of 2 years]
- Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level [Time frame: Through the study completion, an average of 2 years]
- Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level [Time frame: Through the study completion, an average of 2 years]
- ADA and NAb incidence [Time frame: Through the study completion, an average of 2 years]
Eligibility criteria
Inclusion criteria
- 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.
- A life expectancy of ≥ 3 months.
- Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
- Good compliance and willingness to follow up.
Exclusion criteria
- 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.
- Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
- Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
- Clinically active CNS metastases or meningeal metastases.
- A history of other type of malignancies.
- Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
- Poor compliance.
- A history of alcohol/drugs abuse.
- Current pregnancy or breastfeeding.
- Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07107178 · BT02-102