Clinical Trial of BT02 in Patients With Advanced Solid Tumors

NCT06404905 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BT02-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity

  safety

  Within day 28 after administration

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

  Safety

  Within day 28 after administration

• Maximum tolerated dose

  Maximum tolerated dose

  Within day 28 after administration

Secondary Outcomes (5)

• 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.

• 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.

Study Arms (1)

BT02 treatment

EXPERIMENTAL

BT02 given intravenously administer in patients with advanced solid tumors.

Drug: BT02 monoclonal antibody injection

Interventions

BT02 monoclonal antibody injection DRUG

It is expected to include 10-30 patients assigned to dose escalation cohorts.

BT02 treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital

Beijing, Biejing, 1000021, China

RECRUITING

Central Study Contacts

Ning Li, Dr

CONTACT

86 +15601395554; lining@cicas.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 8, 2024
• Study Start: January 24, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)