Clinical Trial of BT02 in Patients With Advanced Solid Tumors
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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
60 participants
Jan 24, 2024
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria11
- 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.
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Interventions
It is expected to include 10-30 patients assigned to dose escalation cohorts.
Locations(1)
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NCT06404905