Testing BT02 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cancer Institute and Hospital
  Beijing, Biejing, China Recruiting

Study contacts

• Study coordinator: Ning Li, Dr
• Email: lining@cicas.ac.cn
• Phone: 86 +15601395554

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.