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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
It is expected to include 10-30 patients assigned to dose escalation cohorts.
Cancer Institute and Hospital
Beijing, Biejing, China
RECRUITINGDose Limiting Toxicity
safety
Time frame: Within day 28 after administration
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Safety
Time frame: Within day 28 after administration
Maximum tolerated dose
Maximum tolerated dose
Time frame: Within day 28 after administration
The Pharmacokinetics characteristics of BT02
Levels of BT02 in blood
Time frame: Within day 28 after administration
Progression-free survival (PFS)
The time from the date of first study treatment to the first occurrence of disease progression.
Time frame: 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.
Overall survival (OS)
The time from the date of first study treatment to death from any cause.
Time frame: 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.
Duration of response
The time from first occurrence of a documented response to disease progression.
Time frame: 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.
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Objective Response Rate (ORR)
The sum of the proportion of subjects with CR or PR
Time frame: 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.