NCT07107178Not yet recruitingPhase 1
A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
A Phase Ib Study of the Safety, Tolerability and Efficacy of BT02 for the Treatment of Patients With Advanced Malignant Melanoma
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 8 Aug 2025
- Primary completion date
- May 2027
- Lead sponsor
- Biotroy Therapeutics
- Diseases
- Melanoma
- NCT number
- NCT07107178
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 58
- From 8 Aug 2025 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
Other illness
- A history of active autoimmune disease within the past 2 years.
- A severe acute or chronic infection when enrollment.
- A history of other type of malignancies.
- A history of alcohol/drugs abuse.
Lab values
- 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.
- 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.
Other
- Clinically active CNS metastases or meningeal metastases.
- Poor compliance.
- Current pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.