Testing BT02 for 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
This study is testing a new drug called BT02 to see if it can help adults with advanced solid tumors feel better and how safe it is.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Biejing) |
| Trial ID | NCT06404905 on ClinicalTrials.gov |
What this trial studies
This is an open-label, first-in-human Phase I/II study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of the monoclonal antibody BT02 in adult patients with advanced solid tumors. Participants will receive BT02 injections and will be monitored for their response to the treatment. The study aims to gather data on how well the drug works and its side effects in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically or cytologically confirmed advanced solid tumors and adequate organ function.
Not a fit: Patients with active autoimmune diseases, significant cardiovascular issues, or those who have received prior anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: Other studies involving monoclonal antibodies for advanced solid tumors have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Biejing
- Cancer Institute and Hospital — Beijing, Biejing, China (Recruiting)
Study contacts
- Study coordinator: Ning Li, Dr
- Email: lining@cicas.ac.cn
- Phone: 86 +15601395554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.