NCT07107178Not yet recruitingPhase 1
A Phase Ib Study of the Safety, Tolerability and Efficacy of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
Not provided0 sites58 target enrollmentStarted: August 8, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 58
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
dose escalation and expansion
Experimental
Intervention: BT02 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Objective response rate (ORR) on tumor assessments(Through the study completion, an average of 2 years)
- Progression-free survival (PFS) on tumor assessments(Through the study completion, an average of 2 years)
- Overall survival (OS)(Through the study completion, an average of 2 years)
- Duration of response (DoR) on tumor assessments(Through the study completion, an average of 2 years)
- Disease control rate (DCR) on tumor assessments(Through the study completion, an average of 2 years)
- ADA and NAb incidence(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(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(Through the study completion, an average of 2 years)
Investigators
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