Advanced Solid Tumor
Conditions
Keywords
Advanced Solid Tumors
Brief 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
Detailed description
Overall study design: This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.
Interventions
DRUGBT02 monoclonal antibody injection
It is expected to include 10-30 patients assigned to dose escalation cohorts.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response | From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months. | The time from first occurrence of a documented response to disease progression. |
| The Pharmacokinetics characteristics of BT02 | Within day 28 after administration | Levels of BT02 in blood |
| Objective Response Rate (ORR) | From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months. | The sum of the proportion of subjects with CR or PR |
| Progression-free survival (PFS) | From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months. | The time from the date of first study treatment to the first occurrence of disease progression. |
| Overall survival (OS) | From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months. | The time from the date of first study treatment to death from any cause. |
Countries
China
Contacts
Primary ContactNing Li, Dr
Outcome results
None listed