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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 site in 1 country60 target enrollmentJanuary 24, 2024

ConditionsAdvanced Solid Tumor

InterventionsBT02 monoclonal antibody injection

DrugsBT02 monoclonal antibody injection

Overview

Phase: Phase 1
Intervention: BT02 monoclonal antibody injection
Conditions: Advanced Solid Tumor
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment: 60
Locations: 1
Primary Endpoint: Dose Limiting Toxicity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 24, 2024

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party

Sponsor

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;

Arms & Interventions

BT02 treatment

BT02 given intravenously administer in patients with advanced solid tumors.

Intervention: BT02 monoclonal antibody injection

Outcomes

Primary Outcomes

Dose Limiting Toxicity

Time Frame: Within day 28 after administration

safety

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Time Frame: Within day 28 after administration

Safety

Maximum tolerated dose

Time Frame: Within day 28 after administration

Maximum tolerated dose

Secondary Outcomes

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.)
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.)
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 Pharmacokinetics characteristics of BT02(Within day 28 after administration)
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.)