Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Official title

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

Overview

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

• Drug BT02 monoclonal antibody injection
  It is expected to include 10-30 patients assigned to dose escalation cohorts.

Primary outcome measures

• Dose Limiting Toxicity [Time frame: Within day 28 after administration]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Within day 28 after administration]
• Maximum tolerated dose [Time frame: Within day 28 after administration]

Secondary outcome measures (5)

• The Pharmacokinetics characteristics of BT02 [Time frame: Within day 28 after administration]
• Progression-free survival (PFS) [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) [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 [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) [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.]

Eligibility criteria

Inclusion criteria

• Age ≥18 at the time of signing the informed consent form, male or female;
• Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
• Adequate organ and hematologic function;
• Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
• ECOG performance status 0\~1;
• Life expectancy ≥ 3 months;
• Good compliance and be willing to follow-up visit.

Exclusion criteria

• Receive treatment before study as below:

a) Previous systematic anti-cancer therapy;

• Active or prior documented autoimmune disease within past 2 years;
• History of clinically significant cardiovascular disease;
• Significant acute or chronic infections;
• Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
• Any prior Grade≥3 irAE while receiving immunotherapy;
• Unstable brain metastasis or meningeal metastasis with clinical symptoms;
• Patients with mental disorders or poor compliance;
• Known alcohol or drug abuse;
• Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Institute and Hospital — Beijing

Identifiers

NCT: NCT06404905 · BT02-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗