Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 1
Started
2024-01-24
Last updated
2024-12-27
Condition(s) studied
Advanced Solid Tumor
Investigational drug(s) / intervention(s)
BT02 monoclonal antibody injection
BT02 monoclonal antibody injection: It is expected to include 10-30 patients assigned to dose escalation cohorts.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 at the time of signing the informed consent form, male or female;
2. Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
3. Adequate organ and hematologic function;
4. Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
5. ECOG performance status 0\~1;
6. Life expectancy ≥ 3 months;
7. Good compliance and be willing to follow-up visit.
Exclusion Criteria:
1. Receive treatment before study as below:
a) Previous systematic anti-cancer therapy;
2. Active or prior documented autoimmune disease within past 2 years;
3. History of clinically significant cardiovascular disease;
4. Significant acute or chronic infections;
5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
6. Any prior Grade≥3 irAE while receiving immunotherapy;
7. Unstable brain metastasis or meningeal metastasis with clinical symptoms;
8. Patients with mental disorders or poor compliance;
9. Known alcohol or drug abuse;
10. Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.
Primary outcome measure(s)
Dose Limiting Toxicity — Within day 28 after administration safety
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) — Within day 28 after administration Safety
Maximum tolerated dose — Within day 28 after administration Maximum tolerated dose
Trial sites (1)
Facility
City
Region
Status
Cancer Institute and Hospital
Beijing
Biejing
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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