A Phase 1 interventional study of BT02 monoclonal antibody injection in Advanced Solid Tumor, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive treatment before study as below:
a) Previous systematic anti-cancer therapy;
BT02 given intravenously administer in patients with advanced solid tumors.
Drug: BT02 monoclonal antibody injection
It is expected to include 10-30 patients assigned to dose escalation cohorts.
Dose 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.
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.
Plan to share: No
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences