A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma

Not Applicable

Not yet recruiting

• Conditions: Advanced Melanoma; Advanced Solid Tumor
• Interventions: Drug: BT02

• Registration Number: NCT07107178

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-08-08
• Primary Completion: 2027-05
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. 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 .
2. Adequate organ and hematologic function.
3. At least 1 extracranial measurable lesion.
4. An ECOG activity status score of 0-1.
5. A life expectancy of ≥ 3 months.
6. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
7. Good compliance and willingness to follow up.

Exclusion Criteria

1. 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.
2. A history of active autoimmune disease within the past 2 years.
3. 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.
4. A severe acute or chronic infection when enrollment.
5. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
6. 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.
7. Clinically active CNS metastases or meningeal metastases.
8. A history of other type of malignancies.
9. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
10. Poor compliance.
11. A history of alcohol/drugs abuse.
12. Current pregnancy or breastfeeding.
13. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
dose escalation and expansion	BT02	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Through the study completion, an average of 2 years
Dose limited toxicity(DLT)	Through the dose escalation phase, an average of 8 months
Maximum tolerable dose(MTD)	Through the dose escalation phase, an average of 8 months
Recommended phase 2 dose(RP2D)	Through the study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
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
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
ADA and NAb incidence	Through the study completion, an average of 2 years