Clinical Trial of BT02 in Patients With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
Key facts
- Study ID
- NCT06404905
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 60
- Starts
- 2024-01-24
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 at the time of signing the informed consent form, male or female;
- Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
- Adequate organ and hematologic function;
- Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
- ECOG performance status 0\~1;
- Life expectancy ≥ 3 months;
- Good compliance and be willing to follow-up visit.
You may not qualify if…
- Receive treatment before study as below:
- a) Previous systematic anti-cancer therapy;
- Active or prior documented autoimmune disease within past 2 years;
- History of clinically significant cardiovascular disease;
- Significant acute or chronic infections;
- Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
- Any prior Grade≥3 irAE while receiving immunotherapy;
- Unstable brain metastasis or meningeal metastasis with clinical symptoms;
- Patients with mental disorders or poor compliance;
- Known alcohol or drug abuse;
- Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.
Where it is running
- Cancer Institute and Hospital — Beijing, Biejing, China (enrolling)
Full record on ClinicalTrials.gov
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